Clinical trial

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

Invitation only · Not applicable · 1 countries · Registry ID NCT04708535

Invitation onlyNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionInsulin Resistance, Insulin Sensitivity, Obesity, Inflammation

Full registry criteria

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.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

T-cell profile in visceral and subcutaneous fatbaseline (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 fatpost-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.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.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(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 phenotypepost-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(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 phenotypespost-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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Stanford University🇺🇸 Stanford, California, United States

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