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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fat tissue might contribute to post-COVID syndrome by causing ongoing inflammation or retaining the virus. It includes a simple fat biopsy (a small tissue sample, known as an adipose tissue biopsy) and a glucose test (Steady State Plasma Glucose, or SSPG, test) to determine insulin sensitivity or resistance in participants. The research aims to understand if obesity and insulin resistance link to long-term COVID effects and could aid in developing new treatments. Participants with a BMI of 25 or higher who are not pregnant are needed. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for post-COVID syndrome.

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.

What prior data suggests that the SSPG Test and Adipose Tissue Biopsy are safe?

Research has shown that taking a small sample of fat tissue, known as an adipose tissue biopsy, is generally safe. This procedure uses a needle to remove a tiny amount of fat. A local anesthetic numbs the area, making the process manageable. Minor discomfort or bruising may occur afterward, but serious complications are rare.

The Steady State Plasma Glucose (SSPG) test commonly assesses how the body processes sugar. This test is also manageable and carries very low risk. Some discomfort from the blood draws may occur, but serious side effects are uncommon.

Both the biopsy and the SSPG test are standard procedures in medical research and are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to understand Post-COVID Syndrome, a condition that current treatments often struggle to address effectively. Unlike traditional methods that might focus on symptom management, this trial uses a combination of the Steady State Plasma Glucose (SSPG) Test and adipose tissue biopsy. The SSPG Test helps determine insulin sensitivity, which could be a key factor in post-COVID symptoms. Meanwhile, the adipose tissue biopsy provides direct insights into how COVID-19 affects body fat, which could reveal new pathways for treatment. By diving deeper into these specific areas, researchers hope to uncover critical data that could lead to more targeted therapies for those suffering from lingering COVID-19 effects.

What evidence suggests that this trial's methods could be effective for studying post-COVID syndrome?

This trial will involve two separate treatment arms to explore the effects of COVID-19 on insulin resistance and fat tissue. In one arm, participants will undergo the Steady State Plasma Glucose (SSPG) test. Research has shown that this test can help identify insulin resistance, a condition often seen in people with long COVID. Studies have found that individuals who have had COVID-19 tend to exhibit higher levels of indicators suggesting insulin resistance, which can exacerbate long COVID symptoms.

In another arm, participants will undergo an adipose tissue biopsy. Evidence suggests that COVID-19 can be present in fat tissue and might contribute to ongoing symptoms. One study found that individuals with more subcutaneous fat might experience more severe long COVID symptoms. Another study indicated that changes in fat tissue following a COVID-19 infection could impact recovery. These findings suggest that both blood sugar testing and understanding changes in fat tissue are important for addressing long COVID. ^{2 6 7 8 9}

Who Is on the Research Team?

Tracey L McLaughlin, MD

Principal Investigator

Stanford School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11514070/

Accumulated subcutaneous fat in abdomen is associated with ... This study suggested that accumulated subcutaneous fat in abdomen (SFA ≥ 2.0 dm 2 ) was an important positive factor associated with long COVID-19 symptoms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11009220/

The interplay of aging, adipose tissue, and COVID-19 This review is dedicated to presenting current evidence concerning the presence of SARS-CoV-2 in the adipose tissue of elderly individuals infected with the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213398425002854

“Association of Body Mass Index on Long COVID ... Preliminary findings indicate that individuals with low BMI may experience poorer recovery outcomes [16], highlighting the need for a more ...

4. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-023-03522-1

Adipose-derived, autologous mesenchymal stem cell therapy ... Treatment with autologous HB-adMSCs resulted in significant improvements in the signs and symptoms associated with post-COVID-19 syndrome as assessed by VAS ...

5. mdpi.com mdpi.com/1422-0067/25/5/2908

Consequences of COVID-19 on Adipose Tissue Signatures This study demonstrates that COVID-19 infection is associated with smaller average adipocyte size. The impact of infection on gene expression was significantly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10932458/

Consequences of COVID-19 on Adipose Tissue Signatures This study demonstrates that COVID-19 infection is associated with smaller average adipocyte size. The impact of infection on gene expression was significantly ...

7. mdpi.com mdpi.com/2075-4426/15/6/217

Improvement of Fatigue and Body Composition in Women ... And those with greater IMF had a higher risk of death. The fat distribution and the differences in body compositions led to different COVID-19 outcomes [26].

8. withpower.com withpower.com/trial/phase-insulin-resistance-4-2023-fd715

SSPG Test + Adipose Tissue Biopsy for Post-COVID ... 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.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1201971222002120

Association of epicardial adipose tissue with the severity ... EAT measures were associated with the severity and adverse clinical outcomes of COVID-19. EAT measures might help in prognostic risk stratification of patients ...