Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported