The Effects of Type of Exercise in Non-alcoholic Fatty Liver Disease
|ClinicalTrials.gov Identifier: NCT02679417|
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : September 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-alcoholic Fatty Liver Disease||Behavioral: exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
12 weeks of aerobic or resistant exercise
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679417
|Faculty of Medicine Siriraj Hospital|
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator:||Phunchai Charatcharoenwitthaya, MD||Faculty of Medicine Siriraj Hospital|