Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18 to 80
BMI ≥ 25 kg/m2
not currently pregnant
Disqualifiers
pregnancy
prior liposuction
recent change in weight (> 2 kg in one month)
bleeding disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Adipose Tissue Biopsy
Procedure/SurgeryAfter 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 testAn 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.
Treatment groups
55 Participants
are divided into 3 treatment groupsGroup A: Chart Review (not actively recruiting)No intervention 0 interventions
Group B: COVID infected and healthy controlsExperimental treatment 1 intervention
Group C: Healthy Controls OnlyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Triglyceride/HDL-cholesterol ratio
Investigate the relationship between insulin resistance, as described by triglyceride/HDL-cholesterol ratio, and incident PASC (long COVID).
Time frame
2 years2
Concentration of Viral RNA in Adipose Tissue
Investigate the expression of viral RNA in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as known MODY transcription factors measured by PCR between COVID-19 infected participants and healthy controls.
Time frame
2 years3
Rate of Inflammatory Response
Investigate inflammatory response to PPARgamma agonist (drug) and other compounds tested in vitro in human fat cells. Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test.
Time frame
2 years4
Rate of Inflammatory Gene Expression in Adipose Tissue
Investigate the expression of inflammatory genes in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as defensin chemokine receptors and platelet activation factors measured by PCR between COVID-19 infected participants and healthy controls.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov