Clinical trial NCT04463667: Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease
Official title: Impact of Exercise Intervention for Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fatty Liver
NAFLD
Keywords: NAFLED
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 20% reduction in intrahepatic fat
timeFrame: 24 weeks.
Secondary outcomes:
measure: Improvement of intrahepatic fibrosis
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine, NTUH
name: Chun-Jen Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: