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

Primary Purpose

Chronic Hepatitis B, Non-alcoholic Fatty Liver Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Metabolic syndrome, Exercise intervention, Fatty liver, Chronic Hepatitis B, Gut microbiota

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

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.

No change in exercise habits and maintaining baseline physical activity.

Outcomes

Primary Outcome Measures

Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF
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 Outcome Measures

Full Information

First Posted
June 13, 2023
Last Updated
July 13, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05956379
Brief Title
Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.
Official Title
Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Patients from NTUH with the diagnosis of chronic HBV infection will be screened for the presence of MAFLD at the out-patient clinics. Treatment naïve patients found to have co-existing MAFLD and willing to join the active exercise program will be invited to join the study by the clinical physicians after thorough evaluation. Patients with age less than 18 years, concurrent HCV or HIV co-infection will be excluded. CHB patients fulfilling reimbursement criteria for the treatment of HBAg-positive or -negative CHB, or advanced fibrosis/cirrhosis will not be enrolled since the virologic profiles under NUC therapy would not likely to be affected by the change of hepatic steatosis through exercise intervention. Assessment of HBV replication status and liver disease severity: The clinical phenotype of HBV infection will be determined by liver function test (serum ALT level) and platelet count number, abdominal ultrasonography, FibroScan™, along with serum HBeAg and HBV DNA level. At enrolment, the patients will be categorized into HBeAg positive chronic HBV infection (immune tolerance phase), HBeAg positive chronic hepatitis B (immune clearance phase), HBeAg negative chronic HBV infection (low replication phase), and HBeAg negative chronic hepatitis B (reactivation phase). The stage of liver fibrosis will determined by FIB-4, FibroScan™and MR elastography (MRE). Diagnosis and assessment of MAFLD: The diagnosis of MAFLD will be made if the patient has evidence of hepatic steatosis by both abdominal ultrasonography and FibroScan™, along with one of the three criteria, namely overweight/obesity, presence of type 2 diabetes mellitus (DM), and at least two metabolic risk abnormalities. Then the degree of hepatic steatosis and fibrosis will be semi-quantitatively assessed by FibroScan™. In this proposal, the investigators will for the first time adopt MR PDFF and MR elastography (MRE) to accurately assess the degree of steatosis and the stage of fibrosis in each enrolled subject before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Non-alcoholic Fatty Liver Disease
Keywords
Metabolic syndrome, Exercise intervention, Fatty liver, Chronic Hepatitis B, Gut microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No change in exercise habits and maintaining baseline physical activity.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of hepatic steatosis after 6-month exercise intervention by MRI-PDFF
Description
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.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Exploratory outcomes
Description
Dynamics of HBV profiles after exercise Impact of diminishing hepatic steatosis on the evolution of liver fibrosis Impact of diminishing hepatic steatosis on the profiles of HBV replication
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Jen Liu, Professor
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongzheng Dist.
ZIP/Postal Code
100229
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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