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

NCT04708535 | Enrolling By Invitation DMC

• 2 other identifiers: 401961-19-ICTS-073
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Resistance; Insulin Sensitivity; Obesity; Inflammation

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  (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.

  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.

  (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.

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

Secondary Outcomes (2)

• Change in body weight

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

• Change in body weight

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Current patients of Stanford Healthcare, Bariatric Surgery Clinic, scheduled to undergo bariatric surgery (sleeve or RYGB)
• BMI 30-55kg/m2
• years of age
• good general health, no major organ disease
• non-diabetic by current American Diabetes Association (ADA) criteria (fasting glucose \<126mg/dl)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• American Heart Association: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Visceral adipose tissue (VAT), Subcutaneous adipose tissue (SAT) and peripheral blood samples are obtained perioperatively.

MeSH Terms

Conditions

Insulin Resistance; Obesity; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Tracey McLaughlin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: January 14, 2021
• Study Start: August 1, 2017
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)