Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes from baseline in the liver fat content at 3 months after intervention.
研究概览
简要总结
NAFLD is increasingly being identified in lean individuals, especially in Chinese population. Among the NAFLD patients, the lean NAFLD accounts for 15.9%-23.0%. Previous studies showed that the lean NAFLD individuals might have a higher risk of severe hepatic disease than those obese individuals. However, the effects of aerobic exercise on the reduction of liver fat content and metabolic risk factors in lean NAFLD individuals remain unknown. In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise) on liver fat content and metabolic risk factors in lean NAFLD individuals.
详细描述
The whole study is divided into four phases: recruitment phase, training phase (1 month, aim to gradually adapt patients to the target exercise intensity), implementation phase (3 months), and follow-up phase (9 months). And the subjects are randomly assigned to two groups: aerobic exercise intervention group and control group.
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
- 30 Years 至 55 Years（Adult）
- 接受健康志愿者
- 否
入选标准
- •Subjects with NAFLD determined by MRI-PDFF (liver fat>5%).
- •Subjects with BMI<23 kg/m
- •Subjects with inactive exercise before.
- •Subjects with basic abilities of understanding, communication and writing.
排除标准
- •Regular drinkers (consumed more than an average of 140 grams of ethanol per week in men and 70 grams in women during the past twelve months).
- •Complicated with other liver diseases (i.e. acute or chronic viral hepatitis, liver cancer, liver cirrhosis, drug-induced liver diseases, and autoimmune hepatitis).
- •Subjects with abnormal liver function (i.e. more than 3 times the upper limit of normal alanine aminotransferase and aspartate aminotransferase).
- •Complicated with severe cardiovascular disease [i.e. myocardial infarction, arrhythmia, heart failure (New York Heart Association III or IV), uncontrolled hypertension (i.e. systolic blood pressure >180 mmHg, and/or diastolic blood pressure >100 mmHg)].
- •Complicated with severe kidney disease or severe renal insufficiency or tumour.
- •Currently pregnant or planning to be pregnant or breast feeding women.
- •Participating in weight loss programs/exercise programs currently or during the past three months.
- •Having any medical condition that would affect metabolism or limit exercise (i.e. diabetes, known hyperthyroidism or hypothyroidism).
- •Having a medical condition that would limit exercise participation or alter heart rate during exercise or taking medication that would affect metabolism or weight loss (i.e. glucocorticoids, antithyroid drugs, hypoglycemic drugs, antihypertensive drugs).
- •Having been doing regular physical exercise for the past three months (i.e. 3 times/week, >30 min/time).
- •Subjects with poor adherence.
结局指标
主要结局
Changes from baseline in the liver fat content at 3 months after intervention.
时间窗: 3 months
The magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is used to detect the liver content. An diagnosis of NAFLD is the liver fat content \> 5%. Changes = (liver fat content at 3 months after intervention - liver fat content at baseline)
次要结局
- Changes from baseline in triglycerides at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in waist hip ratio(WHR) at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in fasting blood glucose at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in fasting insulin at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in abdominal fat at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in glucose level for oral glucose tolerance test (OGTT) at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in body mass index (BMI) at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in blood pressure at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in total cholesterol at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in homeostasis model assessment of β-cell function (HOMA-β) at 3/12 months after intervention.(3 months, 12 months)
- Changes from baseline in the liver fat content at 12 months after intervention.(12 months)
研究者
Qun Zhang
Professor
The First Affiliated Hospital with Nanjing Medical University