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Diabetes Mellitus, Type 1NCT02801942

Immune Profile in Subjects With New Onset Type 1 Diabetes

A study testing Inguinal lymph node fine needle aspirate biopsy, Inguinal lymph node core biopsy and Peripheral blood collection in people with Diabetes Mellitus, Type 1, run by GlaxoSmithKline at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes (iLN), which will be distinct from changes observed in peripheral blood derived immune cells. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Inguinal lymph node fine needle aspirate biopsy, Inguinal lymph node core biopsy and Peripheral blood collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited Kingdom
Study dates
25 Jul 2016to 21 Dec 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between 18 and 40 years of age inclusive, at the time of signing the informed consent.
  • Healthy subjects will be as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination and laboratory tests.
  • Subjects will be considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin (HbA1c), International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count are within the normal range at screening.
  • NOT1D subject with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, with an interval of up to 8 weeks between the initial diagnosis and day 1 of the study (Day 1 = "iLN biopsy" day).
  • NOT1D subject, who currently requires insulin treatment for type 1 diabetes (T1D) and has received insulin therapy for at least 7 days prior to screening.
  • NOT1D subject positive, at screening, for at least one autoantibody associated with T1D: anti- Glutamic Acid Decarboxylase (GAD), anti-Islet antigen 2 (IA-2), anti- islet cell antibodies (ICA), anti-Indole 3 acetic acid (IAA), anti- Zinc transporter 8 (ZnT8).
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  • NOT1D subject with evidence, at screening, of residual functioning beta cells as measured by fasted C-peptide levels >=0.15 nanomole per liter (nmol/L).
  • NOT1D subject having values for the following parameters: INR, APTT, platelet count, red blood cells and total lymphocyte count within the normal range at screening.
  • Both, male or female subjects are eligible to participate in this study. A female subject is only eligible to participate if she is not pregnant [as confirmed by a negative urine human chorionic gonadotropin (hCG) test], not lactating at screening and study visit(s) or has documented evidence to not be of child bearing potential.
  • Capable of giving signed informed consent which includes compliance with the study requirements and study restrictions.
  • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.

Who cannot join

  • Healthy subjects having family history of T1D (that is, first degree relative has been diagnosed with T1D)
  • Healthy subjects with presence of one or more of serum autoantibodies, such as anti-GAD, anti-IA2, anti-ICA, anti-IAA, anti-ZnT8, anti-thyroid peroxidase antibodies, anti-tissue transglutaminase antibodies and anti-nuclear antibodies.
  • NOT1D subjects with history of autoimmune disease other than T1D
  • NOT1D subjects with presence of one or more of serum autoantibodies of the following: anti-thyroid peroxidase antibodies, anti-tissue transglutaminase antibodies or anti-nuclear antibodies
  • Allergy or intolerance to local anesthetic agents
  • Any localized groin condition which would contraindicate biopsy procedure including but not limited to: Active infection/inflammation at the intended puncture site, previous surgery/scarring or any other anatomical abnormality as deemed relevant to the procedure by the investigator, in consultation with the Medical Monitor if required.
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  • History of bleeding disorders, current or anticipated continuous use of anticoagulant (including but not limited to warfarin, rivaroxaban) and antiplatelet agents (including but not limited to Nonsteroidal anti-inflammatory drugs [NSAIDS], clopidogrel, etc.)
  • Active or unresolved bacterial infection, viral infection, fungal infection within 4 weeks prior to day 1.
  • Known febrile episode over 38 degrees Celsius within 4 weeks prior to day 1.
  • Active organ dysfunction or previous organ allograft.
  • History of malignancy (with the exception of resected basal carcinoma of the skin or cervical carcinoma in situ).
  • Has undergone any major surgical procedure within 30 days before screening, and/or is planning to undergo any such surgery during the period of the study (i.e. from screening until the last follow-up telephone call)
  • Present or previous treatment with any cell depleting therapies or immune-modulating or suppressive agents (e.g., oral steroids), including investigational agents such as the following but not limited to e.g., Interleukin (IL)-2, alemtuzumab, anti- Cluster of Differentiation (CD) 4, anti-CD5, anti-CD3, anti-CD19, anti-CD20.
  • Vaccination =<28 days before day 1 of the study or planned during the study period
  • Current participation in an interventional clinical trial. Subjects, who participated in an interventional clinical trial previously, must wait for 3 months after completing the previous interventional clinical trial before participating in this study.
  • Any medical history or clinically relevant abnormality that is deemed by the investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern or any situation that, in the investigator's judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures or to complete all scheduled assessments.
  • A positive pre-study drug/alcohol screen (unless positive due to prescription medication). A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • Inability to access the groin area to perform the biopsy procedure as judged by the investigator.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • GSK Investigational Site

    Cambridge, CB2 0QQ

  • GSK Investigational Site

    Cardiff, CF14 4XN

Other trials in United Kingdom

About this study

Official title: Exploration of the Peripheral Immune System in Subjects With New Onset T1 Diabetes (NOT1D)

It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes (iLN), which will be distinct from changes observed in peripheral blood derived immune cells. Therefore this study will assess and compare the molecular immune profile of cells derived from the iLN in healthy and NOT1D subjects, to understand the immunological processes that may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15 subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy subjects, to determine if the quality and quantity of cells derived from aspirate or core biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its primary objective. An interim analysis will be carried out after the recruitment of 5 evaluable healthy subjects and 5 evaluable NOT1D subjects. The primary purpose of this interim analysis will be to facilitate decision making and study design for a potential follow-up interventional study.

Being tested
Inguinal lymph node fine needle aspirate biopsy, Inguinal lymph node core biopsy, Peripheral blood collection, Pre- and post-biopsy questionnaire
Keywords
Biomarker, Immune Profile, Biopsy, Leukocyte subsets, Inguinal lymph nodes, Type 1 Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inguinal lymph node fine needle aspirate biopsyProcedure or surgery

    Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.

  • Inguinal lymph node core biopsyProcedure or surgery

    Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.

  • Peripheral blood collectionProcedure or surgery

    Blood sample (30 mL) will be collected, to derive immune cells.

  • Pre- and post-biopsy questionnaireOther

    All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.

Study groups in NCT02801942
Study groupRoleWhat they receive
Healthy subjectsExperimentalUp to 30 mL of blood sample will be collected from healthy subjects. Inguinal lymph node fine needle aspirate biopsy and core biopsy will be performed. Leukocyte subset phenotyping will be carried out on iLN-derived cells by assessing expression of (but not restricted to) the following antigens: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD24, CD25, CD38, CD45RA, CD56, Human Leukocyte antigen D related (HLA-DR) and forkhead box P3 protein also called scurfin (FOXP3).
Receives: Procedure: Inguinal lymph node fine needle aspirate biopsy; Procedure: Inguinal lymph node core biopsy; Procedure: Peripheral blood collection; Other: Pre- and post-biopsy questionnaire
Subjects with NOT1DExperimentalUp to 30 mL of blood sample will be collected from subjects with NOT1D. Inguinal lymph node fine needle aspirate biopsy and core biopsy will be performed. Leukocyte subset phenotyping will be carried out on iLN-derived cells by assessing expression of (but not restricted to) the following antigens: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD24, CD25, CD38, CD45RA, CD56, HLA-DR and FOXP3.
Receives: Procedure: Inguinal lymph node fine needle aspirate biopsy; Procedure: Inguinal lymph node core biopsy; Procedure: Peripheral blood collection; Other: Pre- and post-biopsy questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. The analysis was based upon Safety Population which comprised of all participants who complete any study assessment. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Pre Biopsy session on Day 1

  2. Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  3. Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.

    Measured: Pre Biopsy session on Day 1

  4. Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  5. Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.

    Measured: Pre Biopsy session on Day 1

  6. Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  7. Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  8. Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  9. Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.

    Measured: Pre Biopsy session on Day 1

  10. Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  11. Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  12. Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Biopsy session on Day 1

  13. Percentage of Leukocyte Subsets Including Programmed Death 1 (PD-1)+ Inducible Costimulator (ICOS)+ Follicular Helper T (TFH) Cell-like Regulatory (Reg) T Cells in Blood

    Peripheral blood samples were planned to be collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Results could not be presented as data were not collected for this analysis due to lack of model convergence or model reliability

    Measured: Pre Biopsy session on Day 1

  14. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  15. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  16. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Biopsy session on Day 1

  17. Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  18. Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Biopsy session on Day 1

  19. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Pre Biopsy session on Day 1

  20. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  21. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not availble. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Pre Biopsy session on Day 1

  22. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  23. Percentage of Leukocyte Subsets Including Reg T Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  24. Percentage of Leukocyte Subsets Including Reg T Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Biopsy session on Day 1

  25. Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  26. Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  27. Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Pre Biopsy session on Day 1

  28. Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  29. Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  30. Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  31. Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood

    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

    Measured: Pre Biopsy session on Day 1

  32. Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

Secondary outcomes (26)

  1. Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  2. Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  3. Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  4. Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  5. Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates data was not available.

    Measured: Biopsy session on Day 1

  6. Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  7. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  8. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  9. Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  10. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  11. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

    Measured: Biopsy session on Day 1

  12. Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  13. Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  14. Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  15. Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  16. Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA

    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

    Measured: Biopsy session on Day 1

  17. Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations.

    Measured: Up to Day 14

  18. Number of Participants Undergoing Procedure Under Local Anesthetics

    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent procedure under local anesthetics have been presented.

    Measured: Up to Day 4

  19. Number of Participants Undergoing iLN Biopsy Under Local Anesthetics

    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent iLN biopsy under local anesthetics have been presented.

    Measured: Up to Day 4

  20. Number of Participants With Different Reasons for Participating in the Study

    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The different reasons have been listed as follows; have friend with diabetes mellitus (DM)/ to progress knowledge, to improve medicines development, participating in the study because of the honorarium, any other reason not listed above was categorized as "other" and participants having all three reasons as listed above to participate in the study were included in "All reasons" category

    Measured: Up to Day 4

  21. Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy

    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants with extreme anxiety towards the procedure have been presented.

    Measured: Up to Day 4

  22. Number of Participants Looking Forward to Undergo the Procedure

    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants looking forward to undergo the procedure have been presented.

    Measured: Up to Day 4

  23. Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure

    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The aspects better explained were as follows; itself, anesthetic procedure, after-care, none and any other procedure not listed above was categorized as "other".

    Measured: Up to Day 4

  24. Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time

    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who considered to undergo procedure another time have been presented.

    Measured: Up to Day 4

  25. Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy

    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who were encouraged in study for iLN biopsy have been presented.

    Measured: Up to Day 4

  26. Number of Participants Who Appreciated Receiving Study Feedback

    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who appreciated receiving study feedback have been presented.

    Measured: Up to Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study start25 Jul 2016
  3. Primary completion21 Dec 2017
  4. Study completion21 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02801942
Sponsor's protocol ID
203158
Status last verified
Jul 2018
First submitted
13 Jun 2016
Last updated
27 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Inguinal lymph node fine needle aspirate biopsy, Inguinal lymph node core biopsy and Peripheral blood collection in people with Diabetes Mellitus, Type 1, run by GlaxoSmithKline at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood (time frame: Pre Biopsy session on Day 1). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02801942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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