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

NCT ID: NCT04708535

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Insulin Resistance Insulin Sensitivity Obesity Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tracey McLaughlin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracey McLaughlin, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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1-19-ICTS-073

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

40196

Identifier Type: -

Identifier Source: org_study_id