Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2

Not Applicable

Recruiting

• Conditions: Insulin Sensitivity; Insulin Resistance; Long COVID
• Interventions: Procedure: Adipose Tissue Biopsy; Diagnostic Test: Steady State Plasma Glucose (SSPG) Test

• Registration Number: NCT05833217
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-04-27
• Study Start: 2023-06-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-05-02
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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
• diabetes
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID infected and healthy controls	Adipose Tissue Biopsy	Participants will perform a needle fat biopsy for tissue harvesting in the subacute phase (15-30d) of Covid-19 infection or as a healthy control. Our goal is 20 COVID-19 infected participants and 10 healthy controls.
Healthy Controls Only	Steady State Plasma Glucose (SSPG) Test	We are looking for 20 healthy controls for 2 in-person visits on separate days. 1. An Insulin Sensitivity Test (SSPG: Steady State Plasma Glucose) is performed to determine if the participant is insulin-sensitive or insulin resistant. 2. A Needle Fat Biopsy: After an overnight fast, approximately 1-2 grams of subcutaneous fat will be removed by a needle. Patients will have a local anesthetic prior to the procedure.
Healthy Controls Only	Adipose Tissue Biopsy	We are looking for 20 healthy controls for 2 in-person visits on separate days. 1. An Insulin Sensitivity Test (SSPG: Steady State Plasma Glucose) is performed to determine if the participant is insulin-sensitive or insulin resistant. 2. A Needle Fat Biopsy: After an overnight fast, approximately 1-2 grams of subcutaneous fat will be removed by a needle. Patients will have a local anesthetic prior to the procedure.

Primary Outcome Measures

Name	Time	Method
Triglyceride/HDL-cholesterol ratio	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	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	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	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.

Trial Locations

Locations (2)

Clinical and Translational Research Unit; 🇺🇸 Palo Alto, California, United States

Stanford Health; 🇺🇸 Palo Alto, California, United States