Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adipose Tissue Biopsy, Steady State Plasma Glucose (SSPG) Test.
- Who it may be relevant to
- Registry conditions: Long COVID, Insulin Resistance, Insulin Sensitivity. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2 Infection and Inflammation in Human Adipose Tissue
Overview
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.
Interventions
- 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 b
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Clinical and Translational Research Unit — Palo Alto
- Stanford Health — Palo Alto
Identifiers
NCT: NCT05833217 · 69063