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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fatty Liver; NAFLD
• Intervention / Treatment: Other: exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Jen Liu, Doctor; Phone Number: +886972651071; Email: cjliu@ntu.edu.tw
• Study Contact Backup: Name: Ting-Chih Chen; Phone Number: +886920228525; Email: tingchih@g.ntu.edu.tw

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The effects of exercise intervention on fatty liver; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chun-Jen Liu, Doctor, Department of Internal Medicine, NTUH

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: NAFLED
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 202002056RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No