By InvitationNot Applicable

Adaptive Immune Response in Visceral and Subcutaneous Fat: Role in Human Insulin Resistance

United States50 participantsStarted 2017-08-01

Plain-language 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. 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.

Who can participate

Age range

30 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

T-cell profile in visceral and subcutaneous fat

Timeframe: baseline (within 2 months prior to bariatric surgery)

T-cell profile in visceral and subcutaneous fat

Timeframe: post-operatively (1-2 years status post bariatric surgery)

Adipose cell size associated with T cell profile and IR.

Timeframe: baseline (within 2 months prior to bariatric surgery)

Adipose cell size associated with T cell profile and IR.

Timeframe: post-operatively (1-2 years status post bariatric surgery)

Macrophage phenotype

Timeframe: (Timeframe: baseline (within 2 months prior to bariatric surgery)

Macrophage phenotype

Timeframe: post-operatively (1-2 years status post bariatric surgery)

T cell receptor phenotypes

Timeframe: (Timeframe: baseline (within 2 months prior to bariatric surgery)

Trial details

NCT IDNCT04708535

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Insulin Resistance trials

Plain-language summary

Who can participate

Age range

30 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

T-cell profile in visceral and subcutaneous fat

Timeframe: baseline (within 2 months prior to bariatric surgery)

T-cell profile in visceral and subcutaneous fat

Timeframe: post-operatively (1-2 years status post bariatric surgery)

Adipose cell size associated with T cell profile and IR.

Timeframe: baseline (within 2 months prior to bariatric surgery)

Adipose cell size associated with T cell profile and IR.

Timeframe: post-operatively (1-2 years status post bariatric surgery)

Macrophage phenotype

Timeframe: (Timeframe: baseline (within 2 months prior to bariatric surgery)

Macrophage phenotype

Timeframe: post-operatively (1-2 years status post bariatric surgery)

T cell receptor phenotypes

Timeframe: (Timeframe: baseline (within 2 months prior to bariatric surgery)