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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
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 - 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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Chart Review (not actively recruiting) 		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.
Experimental
COVID infected and healthy controls 		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.
  • Procedure: Adipose Tissue Biopsy
    After an overnight fast, approximately 1-2 grams of subcutaneous fat will be removed by a needle. Participants will have a local anesthetic prior to the procedure. The needle fat biopsy will be repeated at quarterly intervals for one year (every 3 months). We will also draw 1 10mL tube of blood at each biopsy for measurement of inflammatory cytokines.
Experimental
Healthy Controls Only 		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.
  • Procedure: Adipose Tissue Biopsy
    After an overnight fast, approximately 1-2 grams of subcutaneous fat will be removed by a needle. Participants will have a local anesthetic prior to the procedure. The needle fat biopsy will be repeated at quarterly intervals for one year (every 3 months). We will also draw 1 10mL tube of blood at each biopsy for measurement of inflammatory cytokines.
  • Diagnostic Test: Steady State Plasma Glucose (SSPG) Test
    An Insulin Sensitivity Test (SSPG: Steady State Plasma Glucose) is performed to determine if participants are insulin sensitive or insulin resistant. This test is approximately 5-6 hours in length. Participants will be asked to fast for 12 hours. The insulin sensitivity test is designed to measure how well your cells remove glucose from your blood in response to insulin. During this test participants will have two small catheters (tubing) placed in their veins (I.V. lines). The total amount of blood that will be drawn during this test will be 140 mL of blood (approximately 9.5 tablespoons). Insulin is a natural hormone, and octreotide (a synthetic hormone) is a drug that temporarily blocks the secretion of insulin from your pancreas. A member of the research team is present and monitoring the results along with the nursing staff.
    Other names:
    • Insulin Sensitivity Test

Recruiting Locations

Stanford Health
Palo Alto, California 94305
Contact:
Nicole Turk, BS
650-888-0144
nturk@stanford.edu

More Details

NCT ID
NCT05833217
Status
Recruiting
Sponsor
Stanford University

Study Contact

Nicole Turk, BS
6508880144
nturk@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.