临床试验/NCT04232566

NCT04232566

招募中

不适用

Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1

Mayo Clinic2 个研究点分布在 1 个国家目标入组 60 人2022年2月20日

适应症Obesity, Morbid NASH - Nonalcoholic Steatohepatitis Chronic Inflammation

干预措施Bariatric surgery

概览

阶段: 不适用
干预措施: Bariatric surgery
疾病 / 适应症: Obesity, Morbid
发起方: Mayo Clinic
入组人数: 60
试验地点: 2
主要终点: Liver fibrosis
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.

注册库

clinicaltrials.gov

开始日期

2022年2月20日

结束日期

2027年12月30日

最后更新

3个月前

研究类型

Observational

性别

All

研究者

发起方

Mayo Clinic

责任方

Principal Investigator

主要研究者

Elena Anna (Eleanna) De Filippis, M.D., Ph.D.

Principal Investigator

Mayo Clinic

入排标准

入选标准

•Undergoing gastric bypass surgery
•Confirmed AUROC F=0 or F\>2 liver fibrosis
•Age 30-70 years
•BMI greater than 40 kg/m2
•Negative pregnancy test (female only)
•Lab Values: Normal TSH

排除标准

•Autoimmune diseases
•Hepatitis B or C positive
•Heavy alcohol use
•Active smoking history
•Active cancer history
•History of asthma
•History of COPD
•Taking Plavix or Coumadin
•Blood donation within past 2 months
•Glucocorticoid Therapy

研究组 & 干预措施

Weight loss surgery

Gastric bypass surgery will be followed by weight loss as standard of care. Liver fibrosis by elastography will be determined before surgery.

干预措施: Bariatric surgery

结局指标

主要结局

Liver fibrosis

时间窗: Baseline

evaluate the liver fibrosis by elastography before surgical intervention

Adipose tissue inflammation

时间窗: Baseline

Evaluate markers of adipose tissue inflammation by mRNA levels

研究点 (2)

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