NCT04232566招募中不适用
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Liver fibrosis
研究概览
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Taking antihistamine on regular basis
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 (Procedure)
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
次要结局
未报告次要终点
研究者
Elena Anna (Eleanna) De Filippis, M.D., Ph.D.
Principal Investigator
Mayo Clinic
研究点 (2)
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