EDISON
Research type
Research Study
Full title
Effects of Dietary Intervention and Surgery on NAFLD (Non-Alcoholic Fatty Liver Disease)
IRAS ID
219190
Contact name
Niall Dempster
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
What effects do low calorie diet and bariatric surgery have on Non-Alcoholic Fatty Liver Disease (NAFLD)?
Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition where fat accumulates in the liver and can lead to inflammation and scarring. It mostly causes no symptoms, however, in the most advanced cases there is an increased risk of liver cancer or liver failure.
NAFLD is currently managed by weight loss and treating associated diseases such as diabetes. No medicines have been licensed to treat it but bariatric surgery has been shown improve it, although it is unknown whether some operations are better than others. It is also unclear whether this is due to general weight loss or other factors.
This study will be conducted in a hospital setting and aims to determine what changes in liver fat and fat processing occur after pre-operative low calorie diet and the two most common types of bariatric surgery. Volunteers who are between 18 and 75 years old, are already scheduled to undergo bariatric surgery diet and have a body mass index between 35 and 55 will usually be eligible to participate; a few will not due to other health conditions, medications, pregnancy or increased alcohol intake. The study duration will be approximately 24 months (approximately 14 months for an individual participant from recruitment to final visit).
Participants will have ten study visits, four of which may be combined with NHS appointments. During them they will undergo scans to look at the liver, fat and muscle and tests to determine how fat is being processed throughout the body. Visits will take place before and after low calorie diet and surgery and in addition to the blood, urine and liver samples taken as part of NHS care, blood, liver and fat will be used for research.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
17/WM/0130
Date of REC Opinion
5 Apr 2017
REC opinion
Further Information Favourable Opinion