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

Insulin Resistance Clinical Trial

Official title:

Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2 Infection and Inflammation in Human Adipose Tissue

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05833217
• Other study ID #: 69063
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Nicole Turk, BS
• Phone: 6508880144
• Email: nturk[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: December 31, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Long COVID

Intervention

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.

Locations

Country	Name	City	State
United States	Clinical and Translational Research Unit	Palo Alto	California
United States	Stanford Health	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride/HDL-cholesterol ratio	Investigate the relationship between insulin resistance, as described by triglyceride/HDL-cholesterol ratio, and incident PASC (long COVID).	2 years
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years