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

NCT05956379 | Enrolling By Invitation

• 1 other identifier: 202212084RINC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B; Non-alcoholic Fatty Liver Disease

Keywords

Metabolic syndrome; Exercise intervention; Fatty liver; Chronic Hepatitis B; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Other Outcomes (1)

• Exploratory outcomes

  24 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Other: exercise

Control group

NO INTERVENTION

No change in exercise habits and maintaining baseline physical activity.

Interventions

exercise OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist., 100229, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Fatty Liver

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chun-Jen Liu, Professor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 21, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)