The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease

September 13, 2016 updated by: Phunchai Charatcharoenwitthaya, Mahidol University

The Effects of Type of Exercise on Hepatic Fat Content and Metabolic Profiles in Non-alcoholic Fatty Liver Disease: A Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aerobic exercise
Each participant reach a minimum of 50 minutes of some form of aerobic exercise including running on a treadmill 5 to 7 days per week for 12 weeks under the supervision of fitness center trainers.
Behavioral: exercise
12 weeks of aerobic or resistant exercise
Active Comparator: resistant exercise
Each participant reach a minimum of 50 minutes of some form of strength training involving repetitions of a resistance training exercise for each major muscle group at an intensity for at least 60% of a one-repetition max, 5 to 7 days per week for 12 weeks under the supervision of fitness center trainers.
Behavioral: exercise
12 weeks of aerobic or resistant exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic fat content as assessed by the controlled attenuation parameter.
Time Frame: 12 weeks
Hepatic fat content will be assessed with the controlled attenuation parameter (CAP) at baseline and the end of 12 weeks. The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic inflammation as assessed by serum levels of aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein.
Time Frame: 12 weeks
Venous blood samples will be obtained for aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein to evaluate the evidence of hepatic inflammation at baseline, 4 weeks, 8 weeks and 112 weeks.
12 weeks
Liver fibrosis as assessed by vibration-controlled transient elastography.
Time Frame: 12 weeks
Liver fibrosis will be acquired by the FibroScan® M probe based on vibration-controlled transient elastography at baseline and the end of 12 weeks. Liver stiffness measurement will be performed by a single operator who is blinded to all clinical data of the patients. Ten successful acquisitions will be performed on each patient. The median value is considered representative of the elastic modulus of the liver expressed in kilopascal (kPa).
12 weeks
Metabolic profiles assessed with the measurement of lipid profiles, plasma glucose, insulin and oral glucose tolerance test.
Time Frame: 12 weeks
Venous blood samples will be obtained after a 12-hour overnight fast for total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol, plasma glucose, insulin, and oral glucose tolerance test at baseline and the end of 12 weeks.
12 weeks
Anthropometry and bioelectrical impedance assessed by a bioelectrical fat analyzer.
Time Frame: 12 weeks
All anthropometric measurements will be performed with the subjects wearing light clothes without shoes at baseline, 4 weeks, 8 weeks and 12 weeks. Height will be measured to the nearest 0.01 m using a calibrated wall-mounted stadiometer. Body weight will be determined to the nearest 0.05 kg using a calibrated balance beam scale. Body mass index will be calculated as weight (kg) divided by the height-squared (m2). Body circumferences will be measured with a flexible tape, with the subject in the upright position at the end of a gentle expiration, at the following levels: waist (midway between the lower rib margin and the superior interior iliac spine) and hip (widest circumference over the great trochanters). Bioelectrical impedance analysis will be performed with the use of a bioelectrical fat analyzer at baseline, 4 weeks, 8 weeks and 12 weeks.
12 weeks
Cardiorespiratory fitness as assessed with maximal oxygen uptake under treadmill test.
Time Frame: 12 weeks
Cardiorespiratory fitness will be assessed by a trained health technician at baseline and the end of 12 weeks. The protocol of treadmill test include a 2-min warm-up, two 3-min exercise stages, and a 2-min cool down period. The protocol goal is to elicit a heart rate that is approximately 75% of the age-predicted maximum (220-age) by the end of the test. Heart rate will be monitored throughout the test, and blood pressure will be measured at the end of each stage. Maximal oxygen uptake (V·O2max) will be estimated using a calculation.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Phunchai Charatcharoenwitthaya, MD, Faculty of Medicine Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

February 6, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 183/2558(EC1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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