Insulin ResistanceNCT04708535
Adaptive Immune Response in Visceral and Subcutaneous Fat: Role in Human Insulin Resistance
An observational study of Insulin Resistance and Insulin Sensitivity, run by Stanford University at 1 site in United States.
Trial summary
The proposed study is designed to test the hypothesis that in human obesity, the balance of pro- and anti-inflammatory T cells in fat tissue is in fact related to macrophage phenotype and insulin resistance, and how it is related. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Insulin Sensitivity, Obesity
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: There are no restrictions in regards to gender, race, or socioeconomic status. The racial/ ethnic composition of the study population will be reflective of the communities surrounding the Stanford University Medical Center.
Who may be able to join
- Current patients of Stanford Healthcare, Bariatric Surgery Clinic, scheduled to undergo bariatric surgery (sleeve or RYGB)
- BMI 30-55kg/m2
- 30-65 years of age
- good general health, no major organ disease
- non-diabetic by current American Diabetes Association (ADA) criteria (fasting glucose <126mg/dl)
Who cannot join
- Subjects with any clinical or biochemical evidence of significant anemia, gastrointestinal, cardiac, hepatic or renal disease will be excluded.
- Subjects with other medical problems may participate as long as the problems are stable.
- Subjects with active psychiatric disorders or past history of bariatric surgery
- Pregnant or lactating women will also be excluded from the study, due to possible risk to the fetus or infant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The proposed study is designed to test the hypothesis that in human obesity, the balance of pro- and anti-inflammatory T cells in fat tissue is in fact related to macrophage phenotype and insulin resistance, and how it is related.
This study is needed to confirm whether conclusions based on studies of visceral adipose tissue in mice are indeed applicable to humans.
We also want to determine the relationship between insulin resistance/hyperinsulinemia and ability to lose weight in obese individuals.
Read the detailed description
Previous studies have found convincing evidence of the relationship between insulin resistance, T cell profiles, macrophage profiles and inflammation of the fat cells. This study will add human subjects to that body of evidence.
Overview Aim 1: Test the hypothesis that the balance of anti- inflammatory vs proinflammatory T cells is protective for systemic insulin resistance. T cell profiles in subcutaneous and visceral tissue and blood will be compared in IR vs IS obese humans at baseline and potentially after 12 months following weight loss. Tcell profile will be evaluated for relationships with IR and inflammation, with adjustment for total body fat. Secondarily, they will be evaluated for relationship to adipose cell size.
Overview Aim 2: Test the hypothesis that macrophage phenotype in adipose tissue is associated with T cell profile and IR. Frequency of macrophage phenotypes (M1 vs M2) will be analyzed in IR vs IS obese humans at baseline and potentially after 12 months following weight loss.
Overview Aim 3: Testing the hypothesis insulin resistance is associated with T cell receptor phenotypes in subcutaneous and visceral tissue. IR and IS subjects will be evaluated at baseline by sequencing of expressed TCRs in paired SAT, VAT, and blood. We will determine whether TCR phenotypes are shared between different IR individuals.
- Conditions
- Insulin Resistance, Insulin Sensitivity, Obesity, Inflammation
- Medical subject headings
- Insulin Resistance, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Cohort | For consenting subjects who are undergoing bariatric surgery, a visceral fat sample will be taken during surgery. In addition to the fat sample, insulin resistance will be measured and determined by a modification of the insulin suppression test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-cell profile in visceral and subcutaneous fat
Pro-inflammatory and anti-inflammatory T cell profiles in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: baseline (within 2 months prior to bariatric surgery)
T-cell profile in visceral and subcutaneous fat
Pro-inflammatory and anti-inflammatory T cell profiles in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: post-operatively (1-2 years status post bariatric surgery)
Adipose cell size associated with T cell profile and IR.
Cell size of subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: baseline (within 2 months prior to bariatric surgery)
Adipose cell size associated with T cell profile and IR.
Cell size of subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: post-operatively (1-2 years status post bariatric surgery)
Macrophage phenotype
Frequency of macrophage phenotype (M1 vs M2) in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: (Timeframe: baseline (within 2 months prior to bariatric surgery)
Macrophage phenotype
Frequency of macrophage phenotype (M1 vs M2) in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: post-operatively (1-2 years status post bariatric surgery)
T cell receptor phenotypes
Frequency of T-cell receptors in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: (Timeframe: baseline (within 2 months prior to bariatric surgery)
T cell receptor phenotypes
Frequency of T-cell receptors in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Measured: post-operatively (1-2 years status post bariatric surgery)
Secondary outcomes (2)
Change in body weight
Percent body weight loss post bariatric surgery, accounting for insulin sensitivity, T-cell profile, cell size, and macrophage and T-cell phenotypes.
Measured: (Timeframe: baseline (within 2 months prior to bariatric surgery)
Change in body weight
Percent body weight loss post bariatric surgery, accounting for insulin sensitivity, T-cell profile, cell size, and macrophage and T-cell phenotypes.
Measured: post-operatively (1-2 years status post bariatric surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Aug 2017
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Tracey McLaughlin, Stanford University
- Investigators
- Tracey McLaughlin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708535
- Sponsor's protocol ID
- 40196
- Other IDs
- 1-19-ICTS-073
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2018
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Immune Response in Visceral and Subcutaneous Fat: Role in Human Insulin Resistance
- ClinicalTrials.gov ID
- NCT04708535
- Acronym / sponsor ID
- 40196
- Conditions
- Insulin Resistance, Insulin Sensitivity, Obesity, Inflammation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Jan 2021 (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 proposed study is designed to test the hypothesis that in human obesity, the balance of pro- and anti-inflammatory T cells in fat tissue is in fact related to macrophage phenotype and insulin resistance, and how it is related.
This study is needed to confirm whether conclusions based on studies of visceral adipose tissue in mice are indeed applicable to humans.
We also want to determine the relationship between insulin resistance/hyperinsulinemia and ability to lose weight in obese individuals.
Detailed description
Previous studies have found convincing evidence of the relationship between insulin resistance, T cell profiles, macrophage profiles and inflammation of the fat cells. This study will add human subjects to that body of evidence.
Overview Aim 1: Test the hypothesis that the balance of anti- inflammatory vs proinflammatory T cells is protective for systemic insulin resistance. T cell profiles in subcutaneous and visceral tissue and blood will be compared in IR vs IS obese humans at baseline and potentially after 12 months following weight loss. Tcell profile will be evaluated for relationships with IR and inflammation, with adjustment for total body fat. Secondarily, they will be evaluated for relationship to adipose cell size.
Overview Aim 2: Test the hypothesis that macrophage phenotype in adipose tissue is associated with T cell profile and IR. Frequency of macrophage phenotypes (M1 vs M2) will be analyzed in IR vs IS obese humans at baseline and potentially after 12 months following weight loss.
Overview Aim 3: Testing the hypothesis insulin resistance is associated with T cell receptor phenotypes in subcutaneous and visceral tissue. IR and IS subjects will be evaluated at baseline by sequencing of expressed TCRs in paired SAT, VAT, and blood. We will determine whether TCR phenotypes are shared between different IR individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric Cohort | – | –For consenting subjects who are undergoing bariatric surgery, a visceral fat sample will be taken during surgery. In addition to the fat sample, insulin resistance will be measured and determined by a modification of the insulin suppression test. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There are no restrictions in regards to gender, race, or socioeconomic status. The racial/ ethnic composition of the study population will be reflective of the communities surrounding the Stanford University Medical Center.
Key inclusion criteria (5 listed)
- Current patients of Stanford Healthcare, Bariatric Surgery Clinic, scheduled to undergo bariatric surgery (sleeve or RYGB)
- BMI 30-55kg/m2
- 30-65 years of age
- good general health, no major organ disease
- non-diabetic by current American Diabetes Association (ADA) criteria (fasting glucose <126mg/dl)
Key exclusion criteria (4 listed)
- Subjects with any clinical or biochemical evidence of significant anemia, gastrointestinal, cardiac, hepatic or renal disease will be excluded.
- Subjects with other medical problems may participate as long as the problems are stable.
- Subjects with active psychiatric disorders or past history of bariatric surgery
- Pregnant or lactating women will also be excluded from the study, due to possible risk to the fetus or infant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T-cell profile in visceral and subcutaneous fat
Time frame: baseline (within 2 months prior to bariatric surgery)
Pro-inflammatory and anti-inflammatory T cell profiles in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
T-cell profile in visceral and subcutaneous fat
Time frame: post-operatively (1-2 years status post bariatric surgery)
Pro-inflammatory and anti-inflammatory T cell profiles in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Adipose cell size associated with T cell profile and IR.
Time frame: baseline (within 2 months prior to bariatric surgery)
Cell size of subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Adipose cell size associated with T cell profile and IR.
Time frame: post-operatively (1-2 years status post bariatric surgery)
Cell size of subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Macrophage phenotype
Time frame: (Timeframe: baseline (within 2 months prior to bariatric surgery)
Frequency of macrophage phenotype (M1 vs M2) in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
Macrophage phenotype
Time frame: post-operatively (1-2 years status post bariatric surgery)
Frequency of macrophage phenotype (M1 vs M2) in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
T cell receptor phenotypes
Time frame: (Timeframe: baseline (within 2 months prior to bariatric surgery)
Frequency of T-cell receptors in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
T cell receptor phenotypes
Time frame: post-operatively (1-2 years status post bariatric surgery)
Frequency of T-cell receptors in subcutaneous adipose tissue and visceral adipose tissue measured via flow cytometry.
2 secondary outcomes
Change in body weight
Time frame: (Timeframe: baseline (within 2 months prior to bariatric surgery)
Change in body weight
Time frame: post-operatively (1-2 years status post bariatric surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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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.
Tracey McLaughlin, MD principal investigator
Stanford University
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 Insulin Resistance and Insulin Sensitivity, run by Stanford University 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 13 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?
This study is still under way. Results are not available in the source record yet.
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?
T-cell profile in visceral and subcutaneous fat (time frame: baseline (within 2 months prior to bariatric surgery)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.