NCT01104220进行中（未招募）不适用
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Insulin sensitivity
研究概览
简要总结
The purpose of this study is to learn more about how the body stores fat in and around organs (for example in the liver) and why this affects some people's health more than others. Understanding this may lead to better treatments for diseases such as diabetes and cardiovascular disease.
详细描述
The purpose of this study is to determine the specific cellular and organ system metabolic and immunologic alterations that are associated with insulin resistance and inflammation in order to identify putative mechanisms and novel bio-markers involved in the pathogenesis and progression of inflammatory and cardiometabolic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lean, metabolically healthy group - Body mass index (BMI) 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.
- •Obese, metabolically healthy group - BMI ≥30 kg/m2, HHbA1C ≤5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.
- •Obese, metabolically healthy group - BMI ≥30 kg/m2, IHTG content ≥5.6% and HbA1C ≥5.7% or fasting plasma glucose concentration ≥100 mg/dl or 2-h OGTT plasma glucose concentration ≥140 mg/dl.
- •Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery - BMI 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration <100 mg/dl, 2-h OGTT plasma glucose concentration <140 mg/dl and IHTG content ≤5%.
- •Obese, scheduled for bariatric and gallbladder surgery - BMI ≥35.0kg/m2
排除标准
- •active or previous history of liver diseases other than NAFLD
- •history of alcohol abuse
- •currently consuming ≥20 g alcohol/day
- •severe hypertriglyceridemia (>300 mg/dL)
- •smoke tobacco
- •cancer diagnosis within the previous 5 years
- •medications that might confound the study results
- •pregnancy or lactation
- •exercise >2 h/week
结局指标
主要结局
Insulin sensitivity
时间窗: Baseline
Insulin sensitivity assessed in vivo by using a hyperinsulinemic-euglycemic clamp procedure with stable isotope tracer infusion
次要结局
- Liver tissue inflammation(Baseline)
- TNF-alpha(Baseline)
- Change in exosome-mediated intercellular signaling(Before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery)
- Interleukin-6 (IL-6)(Baseline)
- Upper vs lower adipose tissue inflammation(Baseline (All groups))
- Exosome-mediated intercellular signaling(Baseline only in all participants)
- Hepatic PNPLA3 synthesis rate(Baseline only in people scheduled for gallbladder or bariatric surgery)
- Abdominal adipose tissue inflammation(Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery)
研究者
研究点 (2)
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