Obesity, Insulin Resistance, and PASC: Persistent SARS-CoV-2 Infection and Inflammation in Human Adipose Tissue
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Triglyceride/HDL-cholesterol ratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 to 80
- •BMI ≥ 25 kg/m2
- •not currently pregnant
排除标准
- •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
- •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
研究组 & 干预措施
COVID infected and healthy controls
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.
干预措施: Adipose Tissue Biopsy (Procedure)
Chart Review (not actively recruiting)
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.
Healthy Controls Only
We are looking for 20 healthy controls for 2 in-person visits on separate days.
- An Insulin Sensitivity Test (SSPG: Steady State Plasma Glucose) is performed to determine if the participant is insulin-sensitive or insulin resistant.
- 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.
干预措施: Adipose Tissue Biopsy (Procedure)
Healthy Controls Only
We are looking for 20 healthy controls for 2 in-person visits on separate days.
- An Insulin Sensitivity Test (SSPG: Steady State Plasma Glucose) is performed to determine if the participant is insulin-sensitive or insulin resistant.
- 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.
干预措施: Steady State Plasma Glucose (SSPG) Test (Diagnostic Test)
结局指标
主要结局
Triglyceride/HDL-cholesterol ratio
时间窗: 2 years
Investigate the relationship between insulin resistance, as described by triglyceride/HDL-cholesterol ratio, and incident PASC (long COVID).
Concentration of Viral RNA in Adipose Tissue
时间窗: 2 years
Investigate the expression of viral RNA in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as known MODY transcription factors measured by PCR between COVID-19 infected participants and healthy controls.
Rate of Inflammatory Response
时间窗: 2 years
Investigate inflammatory response to PPARgamma agonist (drug) and other compounds tested in vitro in human fat cells. Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test.
Rate of Inflammatory Gene Expression in Adipose Tissue
时间窗: 2 years
Investigate the expression of inflammatory genes in adipose tissue in response to COVID-19 infection. Compare adipose tissue transcripts such as defensin chemokine receptors and platelet activation factors measured by PCR between COVID-19 infected participants and healthy controls.
次要结局
未报告次要终点
研究者
Tracey McLaughlin
Professor of Medicine
Stanford University