Non Alcoholic Fatty Liver Disease Clinical Trial
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).
Verified date | September 2014 |
Source | University of Liverpool |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | June 2015 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 ß-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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Surrey County Hospital | Guildford | Surrey |
United Kingdom | University of Surrey | Guildford | Surrey |
United Kingdom | John Moores University | Liverpool | |
United Kingdom | Liverpool University | Liverpool | |
United Kingdom | Royal Liverpool University Hospital | Liverpool | |
United Kingdom | University of Liverpool | Liverpool | |
United Kingdom | Imperial College London | London |
Lead Sponsor | Collaborator |
---|---|
University of Liverpool | Imperial College London, Royal Liverpool University Hospital, Royal Surrey County Hospital, University of Surrey |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in liver and muscle fat | Tissue triglyceride content, or steatosis, will be accurately and non-invasively quantified in vivo using localized proton magnetic resonance spectroscopy (1H MRS). | 4 months | No |
Secondary | Changes in liver function tests | Biochemial measurements of the liver enzymes will be measured pre and post intervention period | 4 months | No |
Secondary | Changes in lipid profiles | Total cholesterol, triglyceride and high density lipoprotien concentrations in fasting state will be measured pre and post intervention period. | 4 months | No |
Secondary | Changes in body weight and anthropometric measurements | Body weight and waist to hip ratio will be measured pre and post intervention period. | 4 months | No |
Secondary | Hepatic insulin sensitivity | 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 | 4 months | No |
Secondary | VLDL-TG kinetics | 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. | 4 months | No |
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