Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2 Infection and Inflammation in Human Adipose Tissue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 55
- Locations
- 4
- Primary Endpoint
- Triglyceride/HDL-cholesterol ratio
Study Overview
Brief Summary
The investigators are studying the pathophysiologic links between obesity, insulin resistance (IR), adipose tissue infection, and post-acute sequelae of COVID-19 (PASC). This study looks at whether adipose (fat) tissue contributes to PASC by driving chronic inflammation or by serving as a reservoir for SARS-CoV-2 persistence. The results will not only determine whether obesity and IR are risk factors for PASC, but will also define fundamental biology that sets the stage for the investigation of novel or existing therapies that target the causal pathways identified.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ages 18 to 80
- •BMI ≥ 25 kg/m2
- •not currently pregnant
Exclusion Criteria
- •Arm 2 (Adipose Tissue Biopsy) exclusions include
- •pregnancy
- •prior liposuction
- •recent change in weight (> 2 kg in one month)
- •bleeding disorders
- •anticoagulant use
- •Arm 3 (healthy controls only) exclusions include patients with
- •major organ disease
- •history of liposuction
- •bariatric surgery
- •eating disorders
- •psychiatric disorders
- •pregnancy or lactation
- •recent change in weight (over the past 12 weeks),
- •use of weight loss medication or oral steroids
- •hematocrit < 33%
- •fasting glucose >= 126 mg/dL
- •blood pressure >160/100 mmHg
Outcomes
Primary Outcomes
Triglyceride/HDL-cholesterol ratio
Time Frame: 2 years
Investigate the relationship between insulin resistance, as described by triglyceride/HDL-cholesterol ratio, and incident PASC (long COVID).
Concentration of Viral RNA in Adipose Tissue
Time Frame: 2 years
Investigate the expression of viral RNA in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as known MODY transcription factors measured by PCR between COVID-19 infected participants and healthy controls.
Rate of Inflammatory Response
Time Frame: 2 years
Investigate inflammatory response to PPARgamma agonist (drug) and other compounds tested in vitro in human fat cells. Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test.
Rate of Inflammatory Gene Expression in Adipose Tissue
Time Frame: 2 years
Investigate the expression of inflammatory genes in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as defensin chemokine receptors and platelet activation factors measured by PCR between COVID-19 infected participants and healthy controls.
Secondary Outcomes
No secondary outcomes reported
Investigators
Tracey McLaughlin
Professor of Medicine
Stanford University