Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.

NCT05956379 · tracked via the Priya Life Science Taiwan tracker

Sponsor

National Taiwan University Hospital

Phase

Not applicable

Started

2023-08-01

Last updated

2023-07-21

Condition(s) studied

Chronic Hepatitis BNon-alcoholic Fatty Liver Disease

Investigational drug(s) / intervention(s)

exercise

exercise: 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. The form of aerobic exercise can be carried out in the form of treadmill walking, walking, jogging, cycling, aerobic dance, ball games, swimming, rope skipping, stepping exercises, etc. When the exercise reaches the target intensity, we will adjust the training intensity process according to personal ability. The physical therapist will again adjust the content of the aerobic exercise program at week 12 based on the reassessment of the exercise capacity.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF — 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.

Trial sites (1)

Facility	City	Region	Status
National Taiwan University Hospital	Taipei	Zhongzheng Dist.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05956379 on ClinicalTrials.gov ↗ ← All trials in Taiwan