NOT_YET_RECRUITING
Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2
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.
Conditions:
🦠 Long COVID 🦠 Insulin Resistance 🦠 Insulin Sensitivity
🗓️ Study Start (Actual) 2 May 2023
🗓️ Primary Completion (Estimated) 2 May 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 55
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Palo Alto, California, United States
📍 Palo Alto, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 April 2023
  • First Submitted that Met QC Criteria 26 April 2023
  • First Posted 27 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 April 2023
  • Last Update Posted 1 May 2023
  • Last Verified April 2023