Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF
研究概览
简要总结
In Taiwan, HBV infection is endemic in the adult population. With the westernization of eating habit and lifestyle, metabolic syndrome and related non-alcoholic fatty liver diseases (NAFLD, newly proposed as metabolic dysfunction associated fatty liver diseases, MAFLD) has become another important health issue. It is therefore common to encounter subjects with concurrent MAFLD and HBV infection in HBV endemic countries. This project will study the clinical data of patients with concurrent MAFLD and HBV, and aim to explore the impact of exercise intervention on the hepatic fatty infiltration, alteration of gut microbiota and HBV replication status in this group of patients. The research strategies will include (1) improving fatty liver and metabolic syndrome in subjects with concurrent MAFLD and HBV; and (2) exploring the changes of HBV replication and intestinal microflora in patients with concurrent HBV and MAFLD after exercise intervention.
详细描述
The investigators will first collect and analyze clinical data of patients with concurrent MAFLD and HBV in a retrospective cohort in NTUH. The investigators aim to clarify the interactions of MAFLD and HBV based on different HBV-related liver disease stage and different metabolic derangement.
Second, using the well-established platform for the detection and staging of fatty liver at NTUH, the investigators plan to enroll 100 patients with concurrent HBV and MAFLD. The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and randomize them to the exercise intervention group (n = 50) and the observation group (n = 50) after conditional screening. After 6-month of exercise intervention, the investigators will analyze the effect of exercise on intrahepatic fat (main parameter: 10% reduction in intrahepatic fat; 30% achieved in the exercise intervention group; 5% achieved in the control group) and analyze the influence of co-existing HBV on the change of hepatic steatosis.
Description of the prospective randomized exercise intervention studies
- Enrolment of 100 patients with concurrent chronic HBV infection and MAFLD
- Collection of baseline data: Clinical parameters, virologic parameters, metabolic and MAFLD parameters, nutritional and exercise fitness data, and liver steatosis/fibrosis data
- Randomization: Randomization into exercise (Group I) versus non-exercise group (Group II) will be conducted with the help of random number table.
- 24-week exercise intervention
- 12-week post-exercise follow-up period
- Collection of final data, statistical analyses and paper preparation
II-1: Enrolment of subjects:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years of age
- •Either gender
- •HBV treatment naïve
- •Capable of taking exercise
- •HBsAg positivity for >6 months
- •Evidence of fatty liver in both abdominal ultrasonography and Fibroscan™(CAP>215)
排除标准
- •Age >70 years of age
- •Evidence of liver cirrhosis
- •Patients fulfilling reimbursement criteria for HBV treatment
- •Evidence of severe cardiopulmonary diseases
- •Evidence of serious hip or knee problems, incapable of taking exercise
- •Evidence of liver decompensation
- •Evidence of active HCV (positive for serum HCV RNA) or HIV infection (positive for anti-HCV)
- •Clinical diagnosis of Alzheimer's Disease
- •Thyroid disease
研究组 & 干预措施
Exercise group
Physical therapists will provide personalized aerobic exercise program prescriptions in the preparatory period based on the results of exercise-related assessments, and the training intensity is based on the results of the maximum exercise test, with moderate intensity for 24 weeks, >=3 cardio workouts per week.
干预措施: exercise (Other)
Control group
No change in exercise habits and maintaining baseline physical activity.
结局指标
主要结局
Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF
时间窗: 24 weeks
We will measure change of hepatic steatosis at week 24 in comparison to baseline steatosis by MRI-PDFF. Reduction of hepatic steatosis by \>=10% will be defined as responder.
次要结局
未报告次要终点