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

Stanford University

Status: Enrolling

Conditions: Long COVID; Insulin Resistance; Insulin Sensitivity

Treatments: Diagnostic Test: Steady State Plasma Glucose (SSPG) Test; Procedure: Adipose Tissue Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05833217

69063

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

Chart Review (not actively recruiting)

No Intervention group

Description:

Chart review of previously consented participants from the entire NIH RECOVER cohort, comprised of 15,000 infected and 2,600 noninfected patients across the country.

COVID infected and healthy controls

Experimental group

Description:

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.

Treatment:

Procedure: Adipose Tissue Biopsy

Healthy Controls Only

Experimental group

Description:

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.

Treatment:

Procedure: Adipose Tissue Biopsy

Diagnostic Test: Steady State Plasma Glucose (SSPG) Test