ECLIPSE Trial
Research type
Research Study
Full title
ECLIPSE: Effect of Carnitine supplementation on Liver steatosis, Insulin sensitivity, Plasma glucose homeostasis, Skeletal muscle metabolism and Energetics: a pilot study.
IRAS ID
228690
Contact name
Guruprasad Aithal
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Non-alcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in industrialised countries, affecting 1 in 4 people. NAFLD occurs when fat accumulates in liver tissue, leading over time to inflammation, scarring and eventually cirrhosis. The burden of NAFLD is projected to eclipse that of alcohol and viral hepatitis, within the next decade. Despite urgent need, however, approved treatment options for this condition are lacking. Enhancing our understanding of the mechanisms governing NAFLD will promote development of effective therapies. Specifically, the relationship between excess liver fat and a range of metabolic abnormalities collectively termed ‘insulin resistance’, is poorly understood and requires clarification.
This research aims to provide detailed insight into the relationship between fat and insulin resistance in liver and muscle tissue, in both healthy volunteers and individuals with NAFLD. We will recruit 20 healthy volunteers with normal liver fat and 40 individuals with NAFLD to assess baseline differences in the way the body handles insulin and glucose, and differences in liver and muscle fat distribution. In NAFLD subjects, we also aim to evaluate whether 6-months’ supplementation with a nutrient called L-carnitine can reduce fat and improve glucose metabolism in liver and muscle. Participants with NAFLD will be randomly allocated to receive either L-carnitine or placebo for 6 months. Liver fat before and after supplementation will be assessed using MRI scans. Insulin resistance in the liver and muscle tissue will be assessed using glucose and insulin infusions.
Given its high prevalence, ideal therapies for NAFLD must be broadly applicable, safe and cost-effective. Carnitine is a widely available dietary supplement with a well-known safety profile and few side effects. This study will use ‘gold-standard’ techniques to evaluate whether carnitine is effective in reducing liver fat and improving metabolism in NAFLD.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0441
Date of REC Opinion
19 Jan 2018
REC opinion
Further Information Favourable Opinion