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Enrolling by invitation NCT04708535

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

— Observational Insulin Resistance Insulin Sensitivity Obesity Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Insulin Resistance, Insulin Sensitivity, Obesity, Inflammation. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • T-cell profile in visceral and subcutaneous fat [Time frame: baseline (within 2 months prior to bariatric surgery)]
  • T-cell profile in visceral and subcutaneous fat [Time frame: post-operatively (1-2 years status post bariatric surgery)]
  • Adipose cell size associated with T cell profile and IR. [Time frame: baseline (within 2 months prior to bariatric surgery)]
  • Adipose cell size associated with T cell profile and IR. [Time frame: post-operatively (1-2 years status post bariatric surgery)]
  • Macrophage phenotype [Time frame: (Timeframe: baseline (within 2 months prior to bariatric surgery)]
  • Macrophage phenotype [Time frame: post-operatively (1-2 years status post bariatric surgery)]
  • T cell receptor phenotypes [Time frame: (Timeframe: baseline (within 2 months prior to bariatric surgery)]
  • T cell receptor phenotypes [Time frame: post-operatively (1-2 years status post bariatric surgery)]
Secondary outcome measures (2)
  • 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)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT04708535 · 40196 · 1-19-ICTS-073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗