SSPG Test + Adipose Tissue Biopsy for Post-COVID Syndrome
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Anticoagulants, Steroids, Weight loss meds
Disqualifiers: Diabetes, Major organ disease, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are using anticoagulants, weight loss medication, or oral steroids, you may not be eligible to participate.
How does the SSPG Test + Adipose Tissue Biopsy treatment for Post-COVID Syndrome differ from other treatments?
This treatment is unique because it combines a specific test (SSPG Test) and a procedure (Adipose Tissue Biopsy) to potentially address Post-COVID Syndrome, whereas there are currently no standard treatments for this condition. The SSPG Test is often used to assess insulin sensitivity, which may provide insights into metabolic changes after COVID-19, while the biopsy could help understand tissue-level effects.
12345Eligibility Criteria
This trial is for adults aged 18 to 80 with a BMI of at least 25 kg/m2, who are not pregnant. It's not for those with high blood pressure, recent significant weight change, fasting glucose >=126 mg/dL, psychiatric disorders, bleeding or major organ diseases, diabetes, history of liposuction or bariatric surgery, and those on certain medications.Inclusion Criteria
You weigh more than what is considered healthy for your height.
Not currently pregnant
I am between 18 and 80 years old.
Exclusion Criteria
Arm 3 (healthy controls only) exclusions include blood pressure >160/100 mmHg
Arm 3 (healthy controls only) exclusions include psychiatric disorders
I have never had weight loss surgery.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo insulin sensitivity testing and needle fat biopsy for tissue harvesting
2 visits
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Participant Groups
The study is examining how obesity and insulin resistance might affect long-term COVID-19 symptoms by testing fat tissue's role in chronic inflammation or as a virus reservoir. Participants will undergo an SSPG test and some may have an adipose tissue biopsy.
3Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Controls OnlyExperimental Treatment2 Interventions
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.
Group II: COVID infected and healthy controlsExperimental Treatment1 Intervention
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.
Group III: Chart Review (not actively recruiting)Active Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clinical and Translational Research UnitPalo Alto, CA
Stanford HealthPalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
COVID-19 pandemic: Can fasting plasma glucose and HbA1c replace the oral glucose tolerance test to screen for hyperglycaemia in pregnancy? [2022]To evaluate proposals considering HbA1c and fasting plasma glucose (FPG) measurement as a substitute for oral glucose tolerance test (OGTT) to diagnose hyperglycaemia in pregnancy (HIP) during COVID-19 pandemic.
Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C. [2022]This study compared the performance of a novel noninvasive technology to fasting plasma glucose (FPG) and A1C tests for detecting undiagnosed diabetes and impaired glucose tolerance.
Approaches to screening for hyperglycaemia in pregnant women during and after the COVID-19 pandemic. [2022]Label="AIM">To evaluate the diagnostic and prognostic performance of alternative diagnostic strategies to oral glucose tolerance tests, including random plasma glucose, fasting plasma glucose and HbA1c , during the COVID-19 pandemic.
Diagnostic accuracy of fasting plasma glucose as a screening test for gestational diabetes mellitus: a systematic review and meta-analysis. [2021]Fasting plasma glucose (FPG) is suggested as a potential screening test for further confirmatory testing by oral glucose tolerance test (OGTT) for diagnosing gestational diabetes mellitus (GDM). The diagnostic accuracy of FPG has been investigated in several studies with varying results. This meta-analysis is done to evaluate the diagnostic accuracy of FPG for the screening of GDM.
Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. [2022]To investigate the relationships between a known history of diabetes and ambient fasting plasma glucose (FPG) levels with death and morbidity rates in patients with severe acute respiratory syndrome (SARS).