Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 2
- 主要终点
- Liver mitochondrial gene expression
研究概览
简要总结
The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.
详细描述
The study has two phases. In Phase I, liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will be tested for the ability to burn fatty acids. In Phase II, patients with nonalcoholic fatty liver disease will participate in either a nine-month lifestyle treatment program or undergo standard care. The goal is to determine how weight loss and exercise improve liver health.
Inpatient comprehensive metabolic tests are performed before and after the nine-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (pre and post-menopausal)
- •Overweight/obese with BMI ≥ 25.9 or < 50.0 kg/m2
- •Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL or 2h glucose 140-200 mg/dL) or diabetes type 2, or undergoing bariatric surgery
- •22-65 years of age
- •Sedentary, < 60 minutes per week of structured physical activity
- •Alcohol intake< 20 g/d
排除标准
- •Having undergone bariatric surgery.
- •Acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy < 1 years
- •Other causes of hepatitis including hepatitis B & C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis, any clinical or biochemical evidence of decompensated liver disease
- •Use of steroids or other drugs that cause NAFLD
- •Pregnant or trying to become pregnant
- •Inability to exercise on a bike or treadmill
结局指标
主要结局
Liver mitochondrial gene expression
时间窗: 1 day
Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation.
次要结局
- Histology to determine the amount of fibrosis in the liver(1 day)
- Liver mitochondrial fat oxidation(1 day)
研究者
Elizabeth Jane Parks
Professor, Nutrition and Exercise Physiology
University of Missouri-Columbia