Status:
COMPLETED
The Effect of Exercise Intervention on Insulin Resistance in Non-alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
Royal Liverpool University Hospital
University of Surrey
Conditions:
Non Alcoholic Fatty Liver Disease
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- Sedentary, non smoking, male subjects,
- Alcohol consumption men \<21 units/week,
- BMI 27-35. (Lean individuals do not suffer from NAFLD, so are not suitable for this study. Conversely, we are restricted to a maximum BMI of 35 due to the size limitations of the MR scanner.)
- A clinical diagnosis of NAFLD based upon the following criteria: i) exclusion of other causes of liver disease i.e. negative Hepatitis B and C serology, a negative auto-immune profile and normal caeruloplasmin concentrations, ii) Ultrasound appearances suggestive of a fatty, echo-bright liver with no evidence of cirrhosis (in some cases, the diagnosis will have been confirmed histologically after liver biopsy.
- Being willing to engage and motivated to follow an exercise program.
Exclusion
- Prescription of corticosteroids, amiodarone, tamoxifen, methotrexate (drugs known to cause secondary steatohepatitis) or fibrates. Statin is Ok as long as the patients are on stable therapy for a while, if changed then the patient will be excluded.
- Alcohol consumption for men 21 units/week.
- A contraindication to exercise (such as unstable ischaemic heart disease),
- Type 2 diabetes (type 2 diabetes patients are excluded so that we are examining the involvement of insulin resistance at a reversible stage before β-cell failure has occurred).
- Patients who are on medications that will interact with GTN (glyceryl trinitrate) will be excluded from the GTN dilatation (endothelial independent NO mediated function) aspect of the study.
- Individuals who suffer from claustrophobia and have metal implants will be excluded from the MRI aspect of the study.
- Patients who smoke will also be excluded from the study.
- Total cholesterol \>7
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01834300
Start Date
January 1 2009
End Date
April 1 2013
Last Update
December 18 2024
Active Locations (7)
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1
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU16 7UJ
2
University of Surrey
Guildford, Surrey, United Kingdom, GU27WG
3
John Moores University
Liverpool, United Kingdom, L3 2ET
4
University of Liverpool
Liverpool, United Kingdom, L69 3GE