Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Primary Purpose
Fatty Liver, NAFLD
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional other trial for Fatty Liver focused on measuring NAFLED
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The effects of exercise intervention on fatty liver
Arm Description
The effects of exercise intervention on fatty liver and the improvement of the above-mentioned various metabolic indicators, including improvement of sleep patterns and changes of intestinal microflora.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04463667
First Posted
June 29, 2020
Last Updated
July 26, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04463667
Brief Title
Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease
Acronym
NAFLD
Official Title
Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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, 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, NAFLD
Keywords
NAFLED
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The effects of exercise intervention on fatty liver
Arm Type
Experimental
Arm Description
The effects of exercise intervention on fatty liver and the improvement of the above-mentioned various metabolic indicators, including improvement of sleep patterns and changes of intestinal microflora.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
20% reduction in intrahepatic fat
Description
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
Time Frame
24 weeks.
Secondary Outcome Measure Information:
Title
Improvement of intrahepatic fibrosis
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Jen Liu, Doctor
Organizational Affiliation
Department of Internal Medicine, NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease
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