Trials / Completed
CompletedNCT01834300
The Effect of Exercise Intervention on Insulin Resistance in Non-alcoholic Fatty Liver Disease (NAFLD)
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).
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University of Liverpool · Academic / Other
- Sex
- All
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This project examines the effects of a 4 month structured exercise intervention program in patients with non-alcoholic fatty liver disease (NAFLD). We will examine changes in total and depot-specific (i.e.in different tissues, liver, muscle and pancreas)fat. We will correlate these with measurements of the insulin from the liver. The hypothesis is that by reducing fat in these specific depots we can reduce insulin resistance and prevent progression to diabetes.
Detailed description
1. 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. 2. 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. 3. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2013-04-17
- Last updated
- 2024-12-18
Locations
7 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01834300. Inclusion in this directory is not an endorsement.