Clinical trial NCT02679417: The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease
Official title: The Effects of Type of Exercise on Hepatic Fat Content and Metabolic Profiles in Non-alcoholic Fatty Liver Disease: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Aminotransferase
Fibrosis, liver
Anthropometry
Exercise
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content in patient with non-alcoholic fatty liver disease (NAFLD) remains unclear. The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.

Detailed description: Increasing prevalence of overweight and obese worldwide, non-alcoholic fatty liver disease (NAFLD) is commonly diagnosed in daily clinical practice. Weight reduction has been the only strategy established thus far to reduce hepatic lipid levels. Thus, dietary restriction and exercise focusing on weight reduction is recommended as the cornerstone for managing NAFLD. Recent reports have indicated that increased exercise greatly reduces hepatic fat accumulation and inflammation and the related oxidative stress levels outweigh those achieved by dietary restriction alone. Clear guidelines for such a "lifestyle physical activity" for NAFLD management are currently lacking. The type of physical activity such as, aerobic or resistant exercise required to reduce liver fat content remains unclear.The purpose of this study is to determine whether aerobic exercise should provide improvement of hepatic fat content and inflammation as well as metabolic profiles and anthropometric parameters better than resistant exercise.

Eligibility criteria: Inclusion Criteria:

* Siriraj medical personals
* Ultrasonography show liver steatosis by using ultrasound criteria
* Transient elastography by using the controlled attenuation parameter show moderate degree of fatty accumulation in the liver
* History of alcohol consumption in male \<20 g/d, female \<10 g/d

Exclusion Criteria:

* Liver disease of other etiology
* Medications that caused fatty accumulation in the liver
* Treated with vitamin E or antidiabetic agents
* Cardiopulmonary diseases or orthopedic conditions that are contraindicated for exercise

Primary outcomes:
measure: Hepatic fat content as assessed by the controlled attenuation parameter.
timeFrame: 12 weeks
Secondary outcomes:
measure: Hepatic inflammation as assessed by serum levels of aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein.
timeFrame: 12 weeks
measure: Liver fibrosis as assessed by vibration-controlled transient elastography.
timeFrame: 12 weeks
measure: Metabolic profiles assessed with the measurement of lipid profiles, plasma glucose, insulin and oral glucose tolerance test.
timeFrame: 12 weeks
measure: Anthropometry and bioelectrical impedance assessed by a bioelectrical fat analyzer.
timeFrame: 12 weeks
measure: Cardiorespiratory fitness as assessed with maximal oxygen uptake under treadmill test.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Phunchai Charatcharoenwitthaya, MD
role: PRINCIPAL_INVESTIGATOR
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