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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05833217
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Adipose Tissue Biopsy — PROCEDURE
    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.
  • Steady State Plasma Glucose (SSPG) Test — DIAGNOSTIC_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.

Study Details

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.

Key Dates

Start date
Jun 6, 2023
Status verified
Dec 2024
Primary completion
May 2, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Triglyceride/HDL-cholesterol ratio [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Clinical and Translational Research UnitPalo AltoCalifornia94304-
Stanford HealthPalo AltoCalifornia94305
Nicole Turk, BS
[email protected]
650-888-0144
Tracey McLaughlin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Clinical and Translational Research Unit· Palo Alto, CAStanford Health· Palo Alto, CA

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