Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- NASH ( Non alcoholic steatohepatitis score) on liver biopsy
研究概览
简要总结
The central hypothesis of this proposal is that a reduction in hepatic mitochondrial function is the main pathophysiology behind NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
详细描述
Fatty Liver Disease) and NASH (Non alcoholic steatohepatitis). The investigators further hypothesize that lifestyle modifications through aerobic exercise training without weight loss or diet-induced weight loss are effective in reducing NAFLD parameters by improving hepatic mitochondrial content and function in human subjects.
The investigators propose a randomized, controlled human clinical trial to compare the effects of aerobic exercise training (without weight loss) versus diet-induced weight loss (without exercise) in individuals who have NAFLD or liver biopsy-confirmed NASH
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sedentary individual between
- •age group 18-60 years old
- •elevated Liver Function Tests (LFT's) with fatty liver on ultrasound and biopsy proven NASH
排除标准
- •significant history of alcohol consumption > 20 gm/day (> 2 drinks / day)
- •evidence of other causes of hepatitis including positive screening B & C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha 1 antitrypsin deficiency or medication-induced hepatitis
- •Subjects with planned exercise > 30-60 minutes per week
- •BMI < 25 or > 44 kg/m2
- •clinical or biochemical evidence of decompensated liver disease, advanced cardiac or renal disease
- •changes in last 3 months the dose of oral hypoglycemic medication and statin,
- •positive stress test
- •pregnant women
- •demented individuals who cannot give consent
结局指标
主要结局
NASH ( Non alcoholic steatohepatitis score) on liver biopsy
时间窗: baseline and 24 weeks
次要结局
- DXA Scan(Baseline and 24 weeks)
- Liver Function Tests(Baseline and 24 weeks)
- Ultrasonographical changes in liver echotexture(Baseline and 24 weeks)
研究者
Jamal Ibdah
Principal Investigator
University of Missouri-Columbia