HivHATIMNCT04451980
The HIV, Adipose Tissue Immunology, and Metabolism Study
An observational study of Hiv and Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
With the introduction of effective anti-retroviral therapy (ART), HIV-infected persons can now survive for decades, but this success has been accompanied by an increased risk of developing metabolic disease and diabetes in HIV-infected persons compared to the general population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Diabetes Mellitus, Type 2
- What is being tested?
- Subcutaneous adipose tissue biopsy, CT scan and Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to 1 May 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-positive participants are recruited from the Vanderbilt Comprehensive Care Clinic, and HIV-negative participants are recruited from Vanderbilt University Medical Center clinics
Who may be able to join
- On antiretroviral therapy for at least 18 months
- HIV-1 RNA <400 copies/ml for the prior 12 months
- CD4+ count >350 cells/µl in the prior 12 months
- HbA1c in prior 6 months within specified limits (See Figure)
- Pre-menopausal by self-report or post-menopausal but not on hormone replacement therapy (HRT)
- A HbA1c >6.5% or a fasting glucose >126mg/dl, or on anti-diabetic medications for at least 6 months
- Pre-menopausal by self-report or post-menopausal but not on hormone replacement therapy (HRT)
Who cannot join
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Current use of DPP-4 inhibitors.
- HIV-negative Participants:
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Current use of DPP-4 inhibitors.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37209
About this study
With the introduction of effective anti-retroviral therapy (ART), HIV-infected persons can now survive for decades, but this success has been accompanied by an increased risk of developing metabolic disease and diabetes in HIV-infected persons compared to the general population. Recent studies from HIV-negative subjects have identified several associations between circulating immune cell populations and impaired glucose tolerance, including increased activated CD4+ and CD8+ T cells, and reduced regulatory T cells. Of note, these same changes in peripheral T cell subsets are frequently observed in patients with chronic HIV infection. The goal of this study is to assess whether the circulating T cell distribution is reflective of the adipose tissue T cell distribution, and to understand whether chronic adipose tissue T cell activation may impair adipocyte (i.e., fat cell) function and insulin sensitivity. If the investigators' hypotheses are correct, this will demonstrate that chronic peripheral immune activation (i.e., high memory T cells, low naïve cells, and increased expression of activation surface markers) is associated with greater adipose-resident CD4+ and CD8+ T cell expression of activation markers, adipose tissue inflammation, and insulin resistance.
Read the detailed description
With the introduction of effective antiretroviral therapy (ART), HIV-infected persons can now survive for decades, but this success has been accompanied by an increased risk of developing metabolic disease compared HIV-negative persons. In the Multicenter AIDS Cohort Study, HIV-infected men had a greater than 4-fold increased incidence of a new diabetes diagnosis compared to HIV-negative men after adjusting for age and body mass index (BMI). Prevalence studies of diabetes in HIV-infected individuals on ART have reported incidence rates of 3.1 to 14 per 1000 patient-years. Furthermore, treated HIV infection appears to act synergistically with other risk factors, and diabetes prevalence is especially high among HIV-infected individuals with high BMI and advanced age.
Recent studies from HIV-negative subjects identified several associations between adaptive immune cell populations and impaired glucose tolerance. Peripheral T regulatory (Treg) cells are significantly lower in patients with type-2 diabetes , while the numbers activated T cells, CD4+ TH1 (pro-inflammatory) cells, and memory CD4+ T cells are higher in diabetics.
Immune cells translocate from the circulation into adipose tissue in a dynamic process, and T cells are present in the stromal fraction of adipose tissue and affect adipocyte function. The striking increase in adipose tissue CD4+ TH1 cells and CD8+ T cells, and a decrease in Treg cells, observed in obesity may have an important role in the development of insulin resistance. Secretion of the proinflammatory cytokines interferon-γ and interleukin (IL)-17 by TH1 and TH17 cells are implicated in the induction of proinflammatory M1 macrophages, which express IL-6 and tumor necrosis factor alpha, and inhibit adipocyte insulin signaling by promoting phosphorylation of insulin receptor substrate 1. The investigators hypothesize that the chronic, HIV-related activation of circulating CD4+ and CD8+ T cells may be accompanied by the accumulation of activated T cells in adipose tissue with adverse effects on metabolic activity.
In this study, the investigators will test the hypothesis that the oligoclonal expansion of chronically activated peripheral T cells in adipose tissue is a primary driver of macrophage inflammation and reduced adipocyte insulin sensitivity. Furthermore, the investigators propose that this represents a central mechanistic linkage underlying the association between circulating T cell activation and incident diabetes risk observed in HIV-infected and HIV-negative individuals.
- Conditions
- Hiv, Diabetes Mellitus, Type 2
- Being tested
- Subcutaneous adipose tissue biopsy, CT scan, Oral glucose tolerance test, Blood collection
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous adipose tissue biopsyProcedure or surgery
Percutaneous adipose tissue biopsy
CT scanRadiation
CT scan of chest and abdomen without contrast
Oral glucose tolerance testDiagnostic test
Ingestion of 75g of oral glucose syrup and measurement of blood glucose and insulin at time 0, 15 min, 30 min, 60 min, 90 min, and 120 min.
Blood collectionDiagnostic test
Fasting blood collection for plasma cytokines and T cell phenotypes.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ non-diabetics | HIV-infected participants with hemoglobin A1c (HbA1c) <5.7% or fasting glucose <100 mg/dl. Receives: Procedure: Subcutaneous adipose tissue biopsy; Radiation: CT scan; Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Blood collection | |
| HIV+ pre-diabetics | HIV-infected participants with HbA1c 5.7-6.4% or fasting glucose 100-125 mg/dl. Receives: Procedure: Subcutaneous adipose tissue biopsy; Radiation: CT scan; Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: Blood collection | |
| HIV+ diabetics | HIV-infected participants with HbA1c >=6.5% or fasting glucose >=126 mg/dl or on anti-diabetic medications. Receives: Procedure: Subcutaneous adipose tissue biopsy; Radiation: CT scan; Diagnostic Test: Blood collection | |
| HIV-negative diabetics | HIV-negative participants with HbA1c >=6.5% or fasting glucose >=126 mg/dl or on anti-diabetic medications. Receives: Procedure: Subcutaneous adipose tissue biopsy; Radiation: CT scan; Diagnostic Test: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue T cell surface marker phenotype and antigen receptor sequence
Flow cytometry measurement of adipose tissue T cell surface marker phenotypes and sequencing of T cell receptors, compared by HIV and diabetes status
Measured: At study enrollment
Secondary outcomes (2)
CT measurements of visceral, hepatic, and pericardial fat content
Quantification of visceral, hepatic, and pericardial adipose tissue content, compared by HIV and diabetes status
Measured: At study enrollment
Circulating T cell surface marker phenotype
Flow cytometry measurement of circulating T cell surface marker phenotypes, compared by HIV and diabetes status
Measured: At study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start31 Aug 2017
- Primary completion13 Mar 2020
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Koethe, Vanderbilt University Medical Center
- Investigators
- John Koethe, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451980
- Sponsor's protocol ID
- 161254
- Acronym
- HATIM
- Status last verified
- May 2026
- First submitted
- 16 Jun 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Wanjalla CN, McDonnell WJ, Barnett L, Simmons JD, Furch BD, Lima MC, Woodward BO, Fan R, Fei Y, Baker PG, Ram R, Pilkinton MA, Mashayekhi M, Brown NJ, Mallal SA, Kalams SA, Koethe JR. Adipose Tissue in Persons With HIV Is Enriched for CD4+ T Effector Memory and T Effector Memory RA+ Cells, Which Show Higher CD69 Expression and CD57, CX3CR1, GPR56 Co-expression With Increasing Glucose Intolerance. Front Immunol. 2019 Mar 19;10:408. doi: 10.3389/fimmu.2019.00408. eCollection 2019.
PubMed 30941121Koethe JR, McDonnell W, Kennedy A, Abana CO, Pilkinton M, Setliff I, Georgiev I, Barnett L, Hager CC, Smith R, Kalams SA, Hasty A, Mallal S. Adipose Tissue is Enriched for Activated and Late-Differentiated CD8+ T Cells and Shows Distinct CD8+ Receptor Usage, Compared With Blood in HIV-Infected Persons. J Acquir Immune Defic Syndr. 2018 Feb 1;77(2):e14-e21. doi: 10.1097/QAI.0000000000001573.
PubMed 29040163Bailin SS, Ma S, Perry AS, Terry JG, Carr JJ, Nair S, Silver HJ, Shi M, Mashayekhi M, Kropski JA, Ferguson JF, Wanjalla CN, Das SR, Shah R, Koethe JR, Gabriel CL. The Primacy of Adipose Tissue Gene Expression and Plasma Lipidome in Cardiometabolic Disease in Persons With HIV. J Infect Dis. 2025 Feb 20;231(2):e407-e418. doi: 10.1093/infdis/jiae532.
PubMed 39657693Swartz AZ, Robles ME, Park S, Esfandiari H, Bradshaw M, Koethe JR, Silver HJ. Cardiometabolic Characteristics of Obesity Phenotypes in Persons With HIV. Open Forum Infect Dis. 2024 Jul 8;11(7):ofae376. doi: 10.1093/ofid/ofae376. eCollection 2024 Jul.
PubMed 39035569Werede AT, Terry JG, Nair S, Temu TM, Shepherd BE, Bailin SS, Mashayekhi M, Gabriel CL, Lima M, Woodward BO, Hannah L, Mallal SA, Beckman JA, Li JZ, Fajnzylber J, Harrison DG, Carr JJ, Koethe JR, Wanjalla CN. Mean Coronary Cross-Sectional Area as a Measure of Arterial Remodeling Using Noncontrast CT Imaging in Persons With HIV. J Am Heart Assoc. 2022 Dec 6;11(23):e025768. doi: 10.1161/JAHA.122.025768. Epub 2022 Nov 16.
PubMed 36382956
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HIV, Adipose Tissue Immunology, and Metabolism Study
- ClinicalTrials.gov ID
- NCT04451980
- Acronym / sponsor ID
- HATIM / 161254
- Conditions
- Hiv, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 30 Jun 2020 (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.
With the introduction of effective anti-retroviral therapy (ART), HIV-infected persons can now survive for decades, but this success has been accompanied by an increased risk of developing metabolic disease and diabetes in HIV-infected persons compared to the general population. Recent studies from HIV-negative subjects have identified several associations between circulating immune cell populations and impaired glucose tolerance, including increased activated CD4+ and CD8+ T cells, and reduced regulatory T cells. Of note, these same changes in peripheral T cell subsets are frequently observed in patients with chronic HIV infection. The goal of this study is to assess whether the circulating T cell distribution is reflective of the adipose tissue T cell distribution, and to understand whether chronic adipose tissue T cell activation may impair adipocyte (i.e., fat cell) function and insulin sensitivity. If the investigators' hypotheses are correct, this will demonstrate that chronic peripheral immune activation (i.e., high memory T cells, low naïve cells, and increased expression of activation surface markers) is associated with greater adipose-resident CD4+ and CD8+ T cell expression of activation markers, adipose tissue inflammation, and insulin resistance.
Detailed description
With the introduction of effective antiretroviral therapy (ART), HIV-infected persons can now survive for decades, but this success has been accompanied by an increased risk of developing metabolic disease compared HIV-negative persons. In the Multicenter AIDS Cohort Study, HIV-infected men had a greater than 4-fold increased incidence of a new diabetes diagnosis compared to HIV-negative men after adjusting for age and body mass index (BMI). Prevalence studies of diabetes in HIV-infected individuals on ART have reported incidence rates of 3.1 to 14 per 1000 patient-years. Furthermore, treated HIV infection appears to act synergistically with other risk factors, and diabetes prevalence is especially high among HIV-infected individuals with high BMI and advanced age.
Recent studies from HIV-negative subjects identified several associations between adaptive immune cell populations and impaired glucose tolerance. Peripheral T regulatory (Treg) cells are significantly lower in patients with type-2 diabetes , while the numbers activated T cells, CD4+ TH1 (pro-inflammatory) cells, and memory CD4+ T cells are higher in diabetics.
Immune cells translocate from the circulation into adipose tissue in a dynamic process, and T cells are present in the stromal fraction of adipose tissue and affect adipocyte function. The striking increase in adipose tissue CD4+ TH1 cells and CD8+ T cells, and a decrease in Treg cells, observed in obesity may have an important role in the development of insulin resistance. Secretion of the proinflammatory cytokines interferon-γ and interleukin (IL)-17 by TH1 and TH17 cells are implicated in the induction of proinflammatory M1 macrophages, which express IL-6 and tumor necrosis factor alpha, and inhibit adipocyte insulin signaling by promoting phosphorylation of insulin receptor substrate 1. The investigators hypothesize that the chronic, HIV-related activation of circulating CD4+ and CD8+ T cells may be accompanied by the accumulation of activated T cells in adipose tissue with adverse effects on metabolic activity.
In this study, the investigators will test the hypothesis that the oligoclonal expansion of chronically activated peripheral T cells in adipose tissue is a primary driver of macrophage inflammation and reduced adipocyte insulin sensitivity. Furthermore, the investigators propose that this represents a central mechanistic linkage underlying the association between circulating T cell activation and incident diabetes risk observed in HIV-infected and HIV-negative individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV+ non-diabetics | – | Procedure: Subcutaneous adipose tissue biopsy, Radiation: CT scan, Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Blood collectionHIV-infected participants with hemoglobin A1c (HbA1c) <5.7% or fasting glucose <100 mg/dl. |
| HIV+ pre-diabetics | – | Procedure: Subcutaneous adipose tissue biopsy, Radiation: CT scan, Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Blood collectionHIV-infected participants with HbA1c 5.7-6.4% or fasting glucose 100-125 mg/dl. |
| HIV+ diabetics | – | Procedure: Subcutaneous adipose tissue biopsy, Radiation: CT scan, Diagnostic Test: Blood collectionHIV-infected participants with HbA1c >=6.5% or fasting glucose >=126 mg/dl or on anti-diabetic medications. |
| HIV-negative diabetics | – | Procedure: Subcutaneous adipose tissue biopsy, Radiation: CT scan, Diagnostic Test: Blood collectionHIV-negative participants with HbA1c >=6.5% or fasting glucose >=126 mg/dl or on anti-diabetic medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-positive participants are recruited from the Vanderbilt Comprehensive Care Clinic, and HIV-negative participants are recruited from Vanderbilt University Medical Center clinics
Key inclusion criteria (7 listed)
- On antiretroviral therapy for at least 18 months
- HIV-1 RNA <400 copies/ml for the prior 12 months
- CD4+ count >350 cells/µl in the prior 12 months
- HbA1c in prior 6 months within specified limits (See Figure)
- Pre-menopausal by self-report or post-menopausal but not on hormone replacement therapy (HRT)
Key exclusion criteria (7 listed)
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
- Current use of DPP-4 inhibitors.
- Known inflammatory or rheumatologic conditions
- Heavy alcohol (>11 drinks per week) or cocaine, amphetamine, or illicit (non-prescribed) opiate abuse by self-report
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 |
|---|---|---|
| Subcutaneous adipose tissue biopsyPercutaneous adipose tissue biopsy | Procedure or surgery | HIV+ diabetics, HIV+ non-diabetics, HIV+ pre-diabetics, HIV-negative diabetics |
| CT scanCT scan of chest and abdomen without contrast | Radiation | HIV+ diabetics, HIV+ non-diabetics, HIV+ pre-diabetics, HIV-negative diabetics |
| Oral glucose tolerance testIngestion of 75g of oral glucose syrup and measurement of blood glucose and insulin at time 0, 15 min, 30 min, 60 min, 90 min, and 120 min. | Diagnostic test | HIV+ non-diabetics, HIV+ pre-diabetics |
| Blood collectionFasting blood collection for plasma cytokines and T cell phenotypes. | Diagnostic test | HIV+ diabetics, HIV+ non-diabetics, HIV+ pre-diabetics, HIV-negative diabetics |
Primary outcome
Adipose tissue T cell surface marker phenotype and antigen receptor sequence
Time frame: At study enrollment
Flow cytometry measurement of adipose tissue T cell surface marker phenotypes and sequencing of T cell receptors, compared by HIV and diabetes status
2 secondary outcomes
CT measurements of visceral, hepatic, and pericardial fat content
Time frame: At study enrollment
Circulating T cell surface marker phenotype
Time frame: At study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 30941121Wanjalla CN, McDonnell WJ, Barnett L, Simmons JD, Furch BD, Lima MC, Woodward BO, Fan R, Fei Y, Baker PG, Ram R, Pilkinton MA, Mashayekhi M, Brown NJ, Mallal SA, Kalams SA, Koethe JR. Adipose Tissue in Persons With HIV Is Enriched for CD4+ T Effector Memory and T Effector Memory RA+ Cells, Which Show Higher CD69 Expression and CD57, CX3CR1, GPR56 Co-expression With Increasing Glucose Intolerance. Front Immunol. 2019 Mar 19;10:408. doi: 10.3389/fimmu.2019.00408. eCollection 2019.
- Results publication: PubMed 29040163Koethe JR, McDonnell W, Kennedy A, Abana CO, Pilkinton M, Setliff I, Georgiev I, Barnett L, Hager CC, Smith R, Kalams SA, Hasty A, Mallal S. Adipose Tissue is Enriched for Activated and Late-Differentiated CD8+ T Cells and Shows Distinct CD8+ Receptor Usage, Compared With Blood in HIV-Infected Persons. J Acquir Immune Defic Syndr. 2018 Feb 1;77(2):e14-e21. doi: 10.1097/QAI.0000000000001573.
- Derived from this study: PubMed 39657693Bailin SS, Ma S, Perry AS, Terry JG, Carr JJ, Nair S, Silver HJ, Shi M, Mashayekhi M, Kropski JA, Ferguson JF, Wanjalla CN, Das SR, Shah R, Koethe JR, Gabriel CL. The Primacy of Adipose Tissue Gene Expression and Plasma Lipidome in Cardiometabolic Disease in Persons With HIV. J Infect Dis. 2025 Feb 20;231(2):e407-e418. doi: 10.1093/infdis/jiae532.
- Derived from this study: PubMed 39035569Swartz AZ, Robles ME, Park S, Esfandiari H, Bradshaw M, Koethe JR, Silver HJ. Cardiometabolic Characteristics of Obesity Phenotypes in Persons With HIV. Open Forum Infect Dis. 2024 Jul 8;11(7):ofae376. doi: 10.1093/ofid/ofae376. eCollection 2024 Jul.
- Derived from this study: PubMed 36382956Werede AT, Terry JG, Nair S, Temu TM, Shepherd BE, Bailin SS, Mashayekhi M, Gabriel CL, Lima M, Woodward BO, Hannah L, Mallal SA, Beckman JA, Li JZ, Fajnzylber J, Harrison DG, Carr JJ, Koethe JR, Wanjalla CN. Mean Coronary Cross-Sectional Area as a Measure of Arterial Remodeling Using Noncontrast CT Imaging in Persons With HIV. J Am Heart Assoc. 2022 Dec 6;11(23):e025768. doi: 10.1161/JAHA.122.025768. Epub 2022 Nov 16.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
John Koethe, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 1 site in United States.
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 7 inclusion and 7 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adipose tissue T cell surface marker phenotype and antigen receptor sequence (time frame: At study enrollment). 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 NCT04451980, which also lists 5 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 5 May 2026.