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Trial record 5 of 345 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

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

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ClinicalTrials.gov Identifier: NCT02679417
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Phunchai Charatcharoenwitthaya, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Behavioral: exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679417


Locations
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Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Phunchai Charatcharoenwitthaya, MD Faculty of Medicine Siriraj Hospital

Publications:

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Responsible Party: Phunchai Charatcharoenwitthaya, Principle Investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT02679417     History of Changes
Other Study ID Numbers: 183/2558(EC1)
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Phunchai Charatcharoenwitthaya, Mahidol University:
Aminotransferase
Fibrosis, liver
Anthropometry
Exercise

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases