The Effect of Exercise Intervention on Insulin Resistance in Non-alcoholic Fatty Liver Disease (NAFLD)
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|ClinicalTrials.gov Identifier: NCT01834300|
Recruitment Status : Unknown
Verified September 2014 by Daniel Cuthbertson, University of Liverpool.
Recruitment status was: Active, not recruiting
First Posted : April 17, 2013
Last Update Posted : September 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Non Alcoholic Fatty Liver Disease||Behavioral: Unsupervised exercise training Behavioral: Supervised exercise training||Not Applicable|
- Exercise program: We are asking people to take part in a supervised exercise program for 4 months. This involves on average a weekly supervised exercise bout plus other unsupervised exercise bouts at home. We will ensure participants are physically able to embark on this by taking their medical history, physical examination and validated questionnaire (PARQ). This program is for the benefit on the patients' long term health.
MR imaging to assess fat: occassionally these may pick up anomalies which require further investigation. A radiologist will screen the abdominal images and GP will be informed on anything requiring further investigation.
No radiation is received during MR imaging.
- Physiological studies: Patients will be asked to attend for 2 non-consecutive days before and after the exercise intervention. Regular blood samples will be required as apart of these investigations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Exercise Training on Visceral Fat, Insulin Sensitivity, β-cell Function and Triglyceride Kinetics in Patients With Non-alcoholic Fatty Liver Disease (NAFLD).|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||June 2015|
Unsupervised exercise training This group will be given 1 hour lifestyle counseling by the exercise trainer after which they will have no contact with the exercise trainer to the end of the intervention period. The exercise intervention will be offered to the subjects once the post studies are completed.
Behavioral: Unsupervised exercise training
The patients will be given lecture on lifestyle changes and its benefitial effects on health at the begining of the study by the exercise trainer. There will be no conatct with the exercise trainer for the period of intervention for 4 months.
Experimental: lifestyle counseling and exercise
Supervised exercise training Four months exercise training intervention will be either gym-based or patients will choose the mode of exercise that suits their lifestyle. Patients will be encouraged to exercise four times per week for 30-45 min at 60-80 % of maximal heart rate, with a 5 min warm-up and warm-down. Participants will be given free access to a variety of affiliated sports centres and will use the Wellness Key system, a software program that enables researchers to remotely track the exercise activity of participants very accurately. To ensure compliance with rest or exercise, all participants of both groups will have their mean physical activity level in 2 non-consecutive weeks evaluated with an ambulatory accelerometer.
Behavioral: Supervised exercise training
Patients will be encouraged to exercise four times per week for 30-45 min at 60-80 % of maximal heart rate, with a 5 min warm-up and warm-down. Participants will be given free access to a variety of affiliated sports centres and will use the Wellness Key system, a software program that enables researchers to remotely track the exercise activity of participants very accurately. To ensure compliance with rest or exercise, all participants of both groups will have their mean physical activity level in 2 non-consecutive weeks evaluated with an ambulatory accelerometer.
- Reduction in liver and muscle fat [ Time Frame: 4 months ]Tissue triglyceride content, or steatosis, will be accurately and non-invasively quantified in vivo using localized proton magnetic resonance spectroscopy (1H MRS).
- Changes in liver function tests [ Time Frame: 4 months ]Biochemial measurements of the liver enzymes will be measured pre and post intervention period
- Changes in lipid profiles [ Time Frame: 4 months ]Total cholesterol, triglyceride and high density lipoprotien concentrations in fasting state will be measured pre and post intervention period.
- Changes in body weight and anthropometric measurements [ Time Frame: 4 months ]Body weight and waist to hip ratio will be measured pre and post intervention period.
- Hepatic insulin sensitivity [ Time Frame: 4 months ]Half of the study cohort i.e. 30 individuals,15 exercise and 15 controls, will have peripheral and hepatic insulin sensitivity determined using a two-stage hyperinsulinaemic, euglycaemic clamp and use of deuterated glucose (2H2-glucose
- VLDL-TG kinetics [ Time Frame: 4 months ]The other half of the study cohort i.e. 30 individuals, 15 exercise and 15 controls, will have VLDL1 and VLDL2 TG kinetics determined using 5H2 glycerol bolus.
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): NCT01834300
|Royal Surrey County Hospital|
|Guildford, Surrey, United Kingdom, GU16 7UJ|
|University of Surrey|
|Guildford, Surrey, United Kingdom, GU27WG|
|John Moores University|
|Liverpool, United Kingdom, L3 2ET|
|University of Liverpool|
|Liverpool, United Kingdom, L69 3GE|
|Royal Liverpool University Hospital|
|Liverpool, United Kingdom, L7 8XP|
|Liverpool, United Kingdom, L9 7AL|
|Imperial College London|
|London, United Kingdom, W12 0HS|
|Study Director:||Daniel Cuthbertson, BSc PhD MRCP||University of Liverpool|
|Principal Investigator:||Fariba Shojaee-Moradie, BSc PhD||University of Surrey|