Type1diabetesNCT05347836
Monocyte Soluble Activation Markers sCD14 and sCD163 in Children With Type 1 Diabetes Mellitus
An observational study of Type1diabetes, run by Assiut University.
Trial summary
The study aims to compare serum levels of sCD14 and sCD163 in children with type 1 Diabetes Mellitus with healthy controls, study the distribution of monocyte subsets in children with T1DM , correlate monocyte subsets and their soluble activation markers sCD14 and sCD163 with parameters reflecting islet β-cell… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- ELISA
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- Child, Adult
Study population: Children with type 1 Diabetes Mellitus Pediatric Endocrinology Unit in Assiut University Children Hospital
Who may be able to join
- Children of any age and sex diagnosed with T1DM (according to WHO criteria) with a minimum duration of five years will be included.
Who cannot join
- Children with other with coexisting autoimmune, chronic, and acute inflammatory diseases.
Trial locations and contacts
No sites are listed yet.
About this study
The study aims to compare serum levels of sCD14 and sCD163 in children with type 1 Diabetes Mellitus with healthy controls, study the distribution of monocyte subsets in children with T1DM , correlate monocyte subsets and their soluble activation markers sCD14 and sCD163 with parameters reflecting islet β-cell insufficiency in children with T1DM.
Read the detailed description
Type 1 diabetes mellitus (T1DM) is T-cell mediated autoimmune disease in which the function of insulin-secreting pancreatic β-cells is impaired due to autoreactive immune cell-mediated destruction (insulitis). Although adaptive immunity has always been the focus for scientists in studying the pathogenesis of T1DM, yet, innate immunity also plays a critical role. Alterations in innate immune responses drive autoimmune pathogenesis, with involvement in the initial break in tolerance and the later failure of regulation. Several studies suggest that the development of T1DM is strongly associated with different immune cells, including monocytes. Specifically, an increase in the monocyte population has been shown to trigger β-cell destruction during insulitis. Intermediate monocytes may serve as M2 macrophage precursors with high anti-inflammatory properties, producing IL-10. However, other studies reported them to have an antigen-presenting function with a dendritic cell-like feature. Upon antigen stimulation, they became the main producers of inflammatory factors, like TNF-α which has been shown to correlate with the severity of T1DM. Activation of circulating monocytes to a pro-inflammatory state induces the shedding of membrane bound CD14 (mCD14) to soluble CD14. Compared to other acute phase proteins, sCD14 was found to be the most sensitive in T1DM. Soluble CD163 is present in blood serum as a result of shedding the CD163 membrane form of activated monocyte-macrophage-lineage cells in the course of inflammation. Plasma sCD163 is widely used as an immunomodulator with anti-inflammatory properties. It was found to be increased in T2DM.
- Conditions
- Type1diabetes
- Being tested
- ELISA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
Determination of serum levels of sCD14 and sCD163 using ELISA
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed to have T1DM with a minimum duration of five years | Not described Receives: Diagnostic Test: ELISA | |
| Healthy children | Not described Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the levels of monocyte soluble activation markers among children with T1DM and healthy controls
To compare the levels of sCD14 and sCD163 among children with T1DM and healthy controls using ELISA
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Maher Mokhtar Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347836
- Sponsor's protocol ID
- Monocyte activation markers
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ismail NA, Abd El Baky AN, Ragab S, Hamed M, Hashish MA, Shehata A. Monocyte chemoattractant protein 1 and macrophage migration inhibitory factor in children with type 1 diabetes. J Pediatr Endocrinol Metab. 2016 Jun 1;29(6):641-5. doi: 10.1515/jpem-2015-0340.
PubMed 27054595Morgan NG, Leete P, Foulis AK, Richardson SJ. Islet inflammation in human type 1 diabetes mellitus. IUBMB Life. 2014 Nov;66(11):723-34. doi: 10.1002/iub.1330. Epub 2014 Dec 11.
PubMed 25504835Kim TK, Lee MS. Innate immune receptors in type 1 diabetes: the relationship to cell death-associated inflammation. Biochem Soc Trans. 2020 Jun 30;48(3):1213-1225. doi: 10.1042/BST20200131.
PubMed 32510139Marshak-Rothstein A. Autoimmunity--promoting and stabilizing innate immunity 'UNWUCHT'. Immunol Rev. 2016 Jan;269(1):7-10. doi: 10.1111/imr.12387. No abstract available.
PubMed 26683141Mysliwska J, Smardzewski M, Marek-Trzonkowska N, Mysliwiec M, Raczynska K. Expansion of CD14+CD16+ monocytes producing TNF-alpha in complication-free diabetes type 1 juvenile onset patients. Cytokine. 2012 Oct;60(1):309-17. doi: 10.1016/j.cyto.2012.03.010. Epub 2012 Apr 7.
PubMed 22484242Ancuta P, Weiss L, Haeffner-Cavaillon N. CD14+CD16++ cells derived in vitro from peripheral blood monocytes exhibit phenotypic and functional dendritic cell-like characteristics. Eur J Immunol. 2000 Jul;30(7):1872-83. doi: 10.1002/1521-4141(200007)30:73.0.CO;2-2.
PubMed 10940876Wong KL, Tai JJ, Wong WC, Han H, Sem X, Yeap WH, Kourilsky P, Wong SC. Gene expression profiling reveals the defining features of the classical, intermediate, and nonclassical human monocyte subsets. Blood. 2011 Aug 4;118(5):e16-31. doi: 10.1182/blood-2010-12-326355. Epub 2011 Jun 7.
PubMed 21653326Harms RZ, Ostlund KR, Cabrera MS, Edwards E, Fisher M, Sarvetnick N. Confirmation and Identification of Biomarkers Implicating Environmental Triggers in the Pathogenesis of Type 1 Diabetes. Front Immunol. 2020 Sep 15;11:1922. doi: 10.3389/fimmu.2020.01922. eCollection 2020.
PubMed 33042112Laursen TL, Wong GL, Kazankov K, Sandahl T, Moller HJ, Hamilton-Dutoit S, George J, Chan HL, Gronbaek H. Soluble CD163 and mannose receptor associate with chronic hepatitis B activity and fibrosis and decline with treatment. J Gastroenterol Hepatol. 2018 Feb;33(2):484-491. doi: 10.1111/jgh.13849.
PubMed 28618015Llaurado G, Gonzalez-Clemente JM, Maymo-Masip E, Subias D, Vendrell J, Chacon MR. Serum levels of TWEAK and scavenger receptor CD163 in type 1 diabetes mellitus: relationship with cardiovascular risk factors. a case-control study. PLoS One. 2012;7(8):e43919. doi: 10.1371/journal.pone.0043919. Epub 2012 Aug 24.
PubMed 22937125Ratajczak W, Atkinson SD, Kelly C. The TWEAK/Fn14/CD163 axis-implications for metabolic disease. Rev Endocr Metab Disord. 2022 Jun;23(3):449-462. doi: 10.1007/s11154-021-09688-4. Epub 2021 Sep 20.
PubMed 34542797
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocyte Soluble Activation Markers sCD14 and sCD163 in Children With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05347836
- Acronym / sponsor ID
- Monocyte activation markers
- Conditions
- Type1diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to compare serum levels of sCD14 and sCD163 in children with type 1 Diabetes Mellitus with healthy controls, study the distribution of monocyte subsets in children with T1DM , correlate monocyte subsets and their soluble activation markers sCD14 and sCD163 with parameters reflecting islet β-cell insufficiency in children with T1DM.
Detailed description
Type 1 diabetes mellitus (T1DM) is T-cell mediated autoimmune disease in which the function of insulin-secreting pancreatic β-cells is impaired due to autoreactive immune cell-mediated destruction (insulitis). Although adaptive immunity has always been the focus for scientists in studying the pathogenesis of T1DM, yet, innate immunity also plays a critical role. Alterations in innate immune responses drive autoimmune pathogenesis, with involvement in the initial break in tolerance and the later failure of regulation. Several studies suggest that the development of T1DM is strongly associated with different immune cells, including monocytes. Specifically, an increase in the monocyte population has been shown to trigger β-cell destruction during insulitis. Intermediate monocytes may serve as M2 macrophage precursors with high anti-inflammatory properties, producing IL-10. However, other studies reported them to have an antigen-presenting function with a dendritic cell-like feature. Upon antigen stimulation, they became the main producers of inflammatory factors, like TNF-α which has been shown to correlate with the severity of T1DM. Activation of circulating monocytes to a pro-inflammatory state induces the shedding of membrane bound CD14 (mCD14) to soluble CD14. Compared to other acute phase proteins, sCD14 was found to be the most sensitive in T1DM. Soluble CD163 is present in blood serum as a result of shedding the CD163 membrane form of activated monocyte-macrophage-lineage cells in the course of inflammation. Plasma sCD163 is widely used as an immunomodulator with anti-inflammatory properties. It was found to be increased in T2DM.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children diagnosed to have T1DM with a minimum duration of five years | – | Diagnostic Test: ELISA |
| Healthy children | – | Diagnostic Test: ELISA |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with type 1 Diabetes Mellitus Pediatric Endocrinology Unit in Assiut University Children Hospital
Key inclusion criteria (1 listed)
- Children of any age and sex diagnosed with T1DM (according to WHO criteria) with a minimum duration of five years will be included.
Key exclusion criteria (1 listed)
- Children with other with coexisting autoimmune, chronic, and acute inflammatory diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISADetermination of serum levels of sCD14 and sCD163 using ELISA | Diagnostic test | Children diagnosed to have T1DM with a minimum duration of five years, Healthy children |
Primary outcome
To compare the levels of monocyte soluble activation markers among children with T1DM and healthy controls
Time frame: Baseline
To compare the levels of sCD14 and sCD163 among children with T1DM and healthy controls using ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 27054595Ismail NA, Abd El Baky AN, Ragab S, Hamed M, Hashish MA, Shehata A. Monocyte chemoattractant protein 1 and macrophage migration inhibitory factor in children with type 1 diabetes. J Pediatr Endocrinol Metab. 2016 Jun 1;29(6):641-5. doi: 10.1515/jpem-2015-0340.
- Background: PubMed 25504835Morgan NG, Leete P, Foulis AK, Richardson SJ. Islet inflammation in human type 1 diabetes mellitus. IUBMB Life. 2014 Nov;66(11):723-34. doi: 10.1002/iub.1330. Epub 2014 Dec 11.
- Background: PubMed 32510139Kim TK, Lee MS. Innate immune receptors in type 1 diabetes: the relationship to cell death-associated inflammation. Biochem Soc Trans. 2020 Jun 30;48(3):1213-1225. doi: 10.1042/BST20200131.
- Background: PubMed 26683141Marshak-Rothstein A. Autoimmunity--promoting and stabilizing innate immunity 'UNWUCHT'. Immunol Rev. 2016 Jan;269(1):7-10. doi: 10.1111/imr.12387. No abstract available.
- Background: PubMed 22484242Mysliwska J, Smardzewski M, Marek-Trzonkowska N, Mysliwiec M, Raczynska K. Expansion of CD14+CD16+ monocytes producing TNF-alpha in complication-free diabetes type 1 juvenile onset patients. Cytokine. 2012 Oct;60(1):309-17. doi: 10.1016/j.cyto.2012.03.010. Epub 2012 Apr 7.
- Background: PubMed 10940876Ancuta P, Weiss L, Haeffner-Cavaillon N. CD14+CD16++ cells derived in vitro from peripheral blood monocytes exhibit phenotypic and functional dendritic cell-like characteristics. Eur J Immunol. 2000 Jul;30(7):1872-83. doi: 10.1002/1521-4141(200007)30:73.0.CO;2-2.
- Background: PubMed 21653326Wong KL, Tai JJ, Wong WC, Han H, Sem X, Yeap WH, Kourilsky P, Wong SC. Gene expression profiling reveals the defining features of the classical, intermediate, and nonclassical human monocyte subsets. Blood. 2011 Aug 4;118(5):e16-31. doi: 10.1182/blood-2010-12-326355. Epub 2011 Jun 7.
- Background: PubMed 33042112Harms RZ, Ostlund KR, Cabrera MS, Edwards E, Fisher M, Sarvetnick N. Confirmation and Identification of Biomarkers Implicating Environmental Triggers in the Pathogenesis of Type 1 Diabetes. Front Immunol. 2020 Sep 15;11:1922. doi: 10.3389/fimmu.2020.01922. eCollection 2020.
- Background: PubMed 28618015Laursen TL, Wong GL, Kazankov K, Sandahl T, Moller HJ, Hamilton-Dutoit S, George J, Chan HL, Gronbaek H. Soluble CD163 and mannose receptor associate with chronic hepatitis B activity and fibrosis and decline with treatment. J Gastroenterol Hepatol. 2018 Feb;33(2):484-491. doi: 10.1111/jgh.13849.
- Background: PubMed 22937125Llaurado G, Gonzalez-Clemente JM, Maymo-Masip E, Subias D, Vendrell J, Chacon MR. Serum levels of TWEAK and scavenger receptor CD163 in type 1 diabetes mellitus: relationship with cardiovascular risk factors. a case-control study. PLoS One. 2012;7(8):e43919. doi: 10.1371/journal.pone.0043919. Epub 2012 Aug 24.
- Background: PubMed 34542797Ratajczak W, Atkinson SD, Kelly C. The TWEAK/Fn14/CD163 axis-implications for metabolic disease. Rev Endocr Metab Disord. 2022 Jun;23(3):449-462. doi: 10.1007/s11154-021-09688-4. Epub 2021 Sep 20.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada M Mokhtar, MD (+201501149921, nadamaher94@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the levels of monocyte soluble activation markers among children with T1DM and healthy controls (time frame: Baseline). 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 NCT05347836, which also lists 11 linked publications.
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 26 Apr 2022.