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

NCT ID: NCT04463667

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Fatty Liver NAFLD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Statistical Center, NTUHCTC

Professor Chun-Jen Liu

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun-Jen Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, NTUH

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Wu CH, Yen KC, Wang LY, Hsieh PL, Wu WK, Lee PL, Liu CJ. Automated Whole-Liver Fat Quantification with Magnetic Resonance Imaging-Derived Proton Density Fat Fraction Map: A Prospective Study in Taiwan. Gut Liver. 2025 Jul 15;19(4):617-626. doi: 10.5009/gnl240408. Epub 2025 Apr 1.

Reference Type DERIVED
PMID: 40169393 (View on PubMed)

Other Identifiers

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202002056RIND

Identifier Type: -

Identifier Source: org_study_id

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