Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 292
- 主要终点
- Liver Stiffness Measurement
研究概览
简要总结
Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.
详细描述
This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or women aged 18-65 years;
- •Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD;
- •Body mass index (BMI)of 25.0 to 35.0 kg/m2;
- •Patients without medicine for treatment of NAFLD;
排除标准
- •Patients with other diseases that can lead to fatty liver;
- •Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months;
- •Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal);
- •Patients with diseases that need control of dietary protein intake;
- •Patients with diseases that affect food digestion and absorption;
- •Patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/L and/or random blood glucose ≥11.1 mmol/L);
- •Patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (Grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment;
- •Patients with secondary obesity;
- •Patients with cancer, active tuberculosis, AIDS and other infectious diseases;
- •Pregnancy or lactation;
- •Physical disability.
研究组 & 干预措施
Lifestyle education
The participants in this group will be provided usual recommendation, including the diet principles, activity guideline and behavioral strategies at baseline. In addition, the participants will have access to an APP, with which the participants could learn more information of body weight management, and keep records of diet, activity and body weight during the study.
干预措施: Lifestyle education (Behavioral)
Intensive Lifestyle Intervention
The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group.
干预措施: Lifestyle education (Behavioral)
Intensive Lifestyle Intervention
The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group.
干预措施: Intensive lifestyle intervention (Behavioral)
Intensive Lifestyle Intervention
The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group.
干预措施: Hypocaloric low-carbohydrate diet plan (Behavioral)
结局指标
主要结局
Liver Stiffness Measurement
时间窗: baseline, 3 month
LSM is suggested as degree of liver fibrosis
Change in liver function biomarkers
时间窗: baseline, 3 month
ALT, AST
Change in BMI
时间窗: baseline, 3 month
Fast Ultrasound Attenuation Parameter
时间窗: baseline, 3 month
FAP is suggested as degree of liver steatosis.
次要结局
- Change in glycemic markers(baseline, 3 month)
- Change in body composition(baseline, 3 month)
- Change in BMI(6 month, 12 month)
- Change in blood pressure(baseline, 3 month)
- Change in liver function biomarkers(6 month, 12 month)
- Change in lipid(baseline, 3 month)
研究者
Liu Zhong
Clinical Professor
First Affiliated Hospital of Zhejiang University