SMASH
Research type
Research Study
Full title
SGLT2 inhibitors and metformin on metabolism and non-alcoholic steatohepatitis (SMASH)
IRAS ID
189361
Contact name
Jeremy Tomlinson
Contact email
Sponsor organisation
Clinical Trials and Research Governance, University of Oxford
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) is very common in patients with diabetes. It is a spectrum of disease that extends from simple fat accumulation in the liver through to irreversible scarring. Up to 16% of patients with diabetes may have the severe form of the disease, often without any symptoms (Armstrong et al. 2014) . Currently, there are no licensed drug treatments available that can modify the disease and it is currently managed through aggressive lifestyle intervention, weight loss and exercise. Many patients with diabetes will be taking the drug metformin to help control their blood sugar levels but it is not clear whether this drug has any impact on liver fat.
Our aim is to perform a small clinical study to see if a new class of tablet to control blood glucose levels in patients with diabetes (the SGLT2 inhibitors) can also reduce fat accumulation in the liver. These drugs work by removing glucose in the urine, thereby decreasing glucose in the blood. We believe that the way in which these drugs act will help the liver reduce the amount of fat that it makes and stores and may be a potential treatment for NAFLD. We also want to look at patients taking metformin to see what impact, if any, this drug has on fat accumulation in the liver. We will perform an MRI scan of participants’ livers and a series of tests to looking at the movement of fat within the body before and after three months of treatment with SGLT2 inhibitor or metformin. This research will provide the first clinical evidence for the use of SGLT2 inhibitors in NAFLD, help clarify the impact of metformin on liver fat and will be highly informative for the design of future clinical studies.
REC name
North of Scotland Research Ethics Committee 2
REC reference
15/NS/0117
Date of REC Opinion
12 Nov 2015
REC opinion
Further Information Favourable Opinion