SSPG Test + Adipose Tissue Biopsy for Post-COVID Syndrome

Recruiting at 1 trial location

Overseen By Tracey McLaughlin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Anticoagulants, Steroids, Weight loss meds

Disqualifiers: Diabetes, Major organ disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 visits

55 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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.

Research Team

Tracey L McLaughlin, MD

Principal Investigator

Stanford School of Medicine

Eligibility 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

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.

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

Treatment Details

Interventions

• Adipose Tissue Biopsy
• Steady State Plasma Glucose (SSPG) Test

Trial Overview 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.

Participant Groups

Group I: Healthy Controls Only Experimental Treatment 2 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 controls Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

The French-speaking Society of Diabetes (SFD) proposal to use HbA1c and fasting plasma glucose (FPG) for diagnosing hyperglycaemia in pregnancy (HIP) showed a low sensitivity of only 57%, indicating it may miss many cases of HIP.

Women diagnosed as false negatives under the SFD criteria had similar rates of HIP-related complications as those diagnosed correctly, suggesting that the alternative diagnostic method does not improve prediction of adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 pandemic: Can fasting plasma glucose and HbA1c replace the oral glucose tolerance test to screen for hyperglycaemia in pregnancy? Nachtergaele, C., Vicaut, E., Pinto, S., et al.[2022]

A novel noninvasive device for detecting diabetes and impaired glucose tolerance demonstrated significantly higher sensitivity (74.7%) compared to fasting plasma glucose (FPG) and A1C tests, identifying 28.8% more individuals than FPG and 17.1% more than A1C.

This noninvasive technology offers a convenient alternative for screening, providing rapid results without the need for fasting or blood draws, making it suitable for opportunistic screening in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C. Maynard, JD., Rohrscheib, M., Way, JF., et al.[2022]

Random plasma glucose at 12 weeks and fasting plasma glucose or HbA1c at 28 weeks can effectively identify pregnant women at risk for gestational diabetes and related complications, with good specificity (up to 98%).

These alternative diagnostic methods provide adequate risk stratification for hyperglycemia-related pregnancy outcomes, especially when traditional oral glucose tolerance tests are unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to screening for hyperglycaemia in pregnant women during and after the COVID-19 pandemic. Meek, CL., Lindsay, RS., Scott, EM., et al.[2022]

Fasting plasma glucose (FPG) at a cut-off of 92 mg/dl shows satisfactory diagnostic accuracy for screening gestational diabetes mellitus (GDM), with a pooled sensitivity of 68.6% and specificity of 93.2% based on a meta-analysis of 29 studies involving 74,481 patients.

The study suggests that while FPG can be a useful screening tool for GDM, further research is needed to confirm its accuracy across different ethnic populations using the oral glucose tolerance test (OGTT) as a reference standard.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of fasting plasma glucose as a screening test for gestational diabetes mellitus: a systematic review and meta-analysis. Li, M., Lan, JR., Liang, JL., et al.[2021]

In a study of 539 patients (135 deceased from SARS, 385 survivors, and 19 with non-SARS pneumonia), a known history of diabetes and elevated fasting plasma glucose (FPG) levels were found to be significant predictors of mortality in SARS patients.

Patients with higher FPG levels (≥7.0 mmol/l) before steroid treatment had a threefold increased risk of death, suggesting that managing blood sugar levels could potentially improve outcomes for those affected by SARS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Yang, JK., Feng, Y., Yuan, MY., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

COVID-19 pandemic: Can fasting plasma glucose and HbA1c replace the oral glucose tolerance test to screen for hyperglycaemia in pregnancy? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Noninvasive type 2 diabetes screening: superior sensitivity to fasting plasma glucose and A1C. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Approaches to screening for hyperglycaemia in pregnant women during and after the COVID-19 pandemic. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of fasting plasma glucose as a screening test for gestational diabetes mellitus: a systematic review and meta-analysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. [2022]