RecruitingRecruiting
Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2
NCT05833217 · Stanford University
In plain English
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Official title
Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2 Infection and Inflammation in Human Adipose Tissue
About this study
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
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 target: 55 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-06-06
Estimated completion: 2025-12-31
Last updated: 2024-12-04
Interventions
Procedure: Adipose Tissue BiopsyDiagnostic Test: Steady State Plasma Glucose (SSPG) Test
Primary outcomes
- • Triglyceride/HDL-cholesterol ratio (2 years)
- • Concentration of Viral RNA in Adipose Tissue (2 years)
- • Rate of Inflammatory Response (2 years)
Sponsor
Stanford University · other
Contacts & investigators
ContactNicole Turk, BS · contact · nturk@stanford.edu · 6508880144
InvestigatorTracey McLaughlin, MD · principal_investigator, Stanford School of Medicine
All locations (2)
Clinical and Translational Research UnitEnrolling By Invitation
Palo Alto, California, United States
Stanford HealthRecruiting
Palo Alto, California, United States