Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2
NCT ID: NCT05833217
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
55 participants
INTERVENTIONAL
2023-06-06
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 25 kg/m2
* not currently pregnant
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Tracey McLaughlin
Professor of Medicine
Principal Investigators
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Tracey McLaughlin, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford School of Medicine
Locations
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Clinical and Translational Research Unit
Palo Alto, California, United States
Stanford Health
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69063
Identifier Type: -
Identifier Source: org_study_id