Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT05833217

Conditions

Long COVID

Insulin Resistance

Insulin Sensitivity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Adipose Tissue Biopsy

Steady State Plasma Glucose (SSPG) Test

Study Details

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.

Conditions

Long COVID

Insulin Resistance

Insulin Sensitivity

Study ID

NCT05833217

Start date

Jun 6, 2023

Status verified date

Dec, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

May 2, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

55 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Triglyceride/HDL-cholesterol ratio [ Time Frame: 2 years ]
  • Concentration of Viral RNA in Adipose Tissue [ Time Frame: 2 years ]
  • Rate of Inflammatory Response [ Time Frame: 2 years ]
  • Rate of Inflammatory Gene Expression in Adipose Tissue [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Nicole Turk, BS

6508880144nturk@stanford.edu

Locations

Stanford Health

Recruiting

Palo Alto, California, United States, 94305

Contacts

Nicole Turk, BS

650-888-0144nturk@stanford.edu

Principal Investigator:

Tracey McLaughlin, MD

More Information

Sponsor

Stanford University

Last update posted

Dec 4, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-12-04.