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

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
exercise
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Aminotransferase, Fibrosis, liver, Anthropometry, Exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

aerobic exercise

resistant exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hepatic fat content as assessed by the controlled attenuation parameter.
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.

Secondary Outcome Measures

Hepatic inflammation as assessed by serum levels of aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein.
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.
Liver fibrosis as assessed by vibration-controlled transient elastography.
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).
Metabolic profiles assessed with the measurement of lipid profiles, plasma glucose, insulin and oral glucose tolerance test.
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.
Anthropometry and bioelectrical impedance assessed by a bioelectrical fat analyzer.
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.
Cardiorespiratory fitness as assessed with maximal oxygen uptake under treadmill test.
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.

Full Information

First Posted
January 29, 2016
Last Updated
September 13, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02679417
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Aminotransferase, Fibrosis, liver, Anthropometry, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
resistant exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
12 weeks of aerobic or resistant exercise
Primary Outcome Measure Information:
Title
Hepatic fat content as assessed by the controlled attenuation parameter.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hepatic inflammation as assessed by serum levels of aspartate aminotransferase, alanine aminotransferase, ferritin and c-reactive protein.
Description
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.
Time Frame
12 weeks
Title
Liver fibrosis as assessed by vibration-controlled transient elastography.
Description
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).
Time Frame
12 weeks
Title
Metabolic profiles assessed with the measurement of lipid profiles, plasma glucose, insulin and oral glucose tolerance test.
Description
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.
Time Frame
12 weeks
Title
Anthropometry and bioelectrical impedance assessed by a bioelectrical fat analyzer.
Description
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.
Time Frame
12 weeks
Title
Cardiorespiratory fitness as assessed with maximal oxygen uptake under treadmill test.
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phunchai Charatcharoenwitthaya, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease

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