Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease

NAFLD Clinical Trial

— NAFLD  

Official title:

Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04463667
• Other study ID #: 202002056RIND
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Taiwan, with the westernization of eating habit and lifestyle, metabolic syndrome and non-alcoholic fatty liver (NAFLD) have become very important health issues. This project will therefore study the histological and clinical data of patients with non-alcoholic fatty liver disease and explore the impact of exercise intervention on the hepatic fatty infiltration of the patients. The research strategy will include (1) combining modern artificial big data collection technology to fully monitor the daily life, sleep and exercise patterns of the participants; (2) improving fatty liver and metabolic syndrome through trial-based exercise intervention; and (3) exploring the changes of sleep patterns and intestinal microflora in patients with metabolic liver disease after exercise intervention.

Description:

Background & aims: In Taiwan, with the investigators sternization of eating habit and lifestyle, metabolic syndrome and non-alcoholic fatty liver (NAFLD) have become very important health issues. This project will therefore study the histological and clinical data of patients with non-alcoholic fatty liver disease and explore the impact of exercise intervention on the hepatic fatty infiltration of the patients. The research strategy will include (1) combining modern artificial big data collection technology to fully monitor the daily life, sleep and exercise patterns of the participants; (2) improving fatty liver and metabolic syndrome through trial-based exercise intervention; and (3) exploring the changes of sleep patterns and intestinal microflora in patients with metabolic liver disease after exercise intervention.

Materials & methods: The investigators will first retrospective collect clinical and histologic data of patients with biopsy proven NAFLD. Second, the investigators will establish a non-invasive fatty liver detection and staging platform at National Taiwan University Hospital. The investigators then plan to enroll 100 patients with non-alcoholic fatty liver from NTUH employees. The investigators will collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening. After one year of exercise intervention, the investigators will analyze the effect of exercise on intrahepatic fat (main parameter: 20% reduction in intrahepatic fat; 30% achieved in the exercise intervention group; 5% achieved in the control group) and related metabolic syndrome indicators, and analyze different types of exercise Whether the intervention has different effects, and analyze the improvement of sleep pattern and intestinal microflora after exercise intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• non-alcoholic fatty liver from NTUH employees

Exclusion Criteria:

• not suitable for exercise (severe cardiovascular disease or severe limb and joint disease), patients with inherited hyperlipidemia (diabetes> 300 mg / dL or low-density lipoprotein cholesterol> 190 mg / dL or cardiovascular disease has occurred before the age of 60 )event).

• women exclude pregnancy and breastfeeding.

• liver cancer, AFP> 20 ng/ml.

• alcohol and drug abusers.

• the use of steroids, sex hormones, immunosuppressants, radiation exposure and chemotherapy within 3 months.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• exercise
Collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20% reduction in intrahepatic fat	We aim to evaluate whether active exercise can help reduce the fat content of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by MRS/PDFF	24 weeks.
Secondary	Improvement of intrahepatic fibrosis	We also aim to evaluate whether active exercise can help reduce the fibrosis of the liver. After 24-week exercise intervention, the effect of exercise on the reduction of intrahepatic fat content in cases (active exercise) versus controls (no exercise) will be assessed by Fibroscan examination.	24 weeks