The COMBINE Trial
Research type
Research Study
Full title
Combining structured exercise with a high protein low energy diet to attenuate lean mass loss in South Asian adults living with Type 2 Diabetes: The COMBINE trial
IRAS ID
326665
Contact name
Thomas Yates
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Type 2 diabetes is 4 to 6 times more common in South Asian adults and can occur up to 10 years earlier. This is worrying because South Asian individuals are more likely to develop heart, kidney and physical function problems.
However, many of these effects have been shown to be reversible with weight loss caused by a low energy diet, which can lead to the remission of diabetes in some people. However, one third of weight lost through a low energy diet is lean muscle which might have negative consequences for long term health.
The overall aim of the COMBINE study and the optional sub study is to investigate whether the combination of a structured exercise programme and a low energy diet can reduce the amount of muscle lost compared to a low energy diet alone.
In total, 36 (up to 20 for the sub study) individuals of South Asian descent (aged 40-65) will be randomly assigned to: a high protein low energy diet or a combination of an exercise programme and a high protein low energy diet for 12 weeks.
High protein low energy diet - These participants will receive high protein meal replacement products with added protein that replace all meals for 12 weeks.
Low energy diet and exercise - These participants will receive high protein meal replacement products for 12 weeks and will also take part in supervised exercise three times each week (from weeks 1-12).
After 12 weeks, participants will be supported through food reintroduction and exercise self management for 4 weeks.
We will look at differences in muscle mass and quality between groups and check how many people reversed their type 2 diabetes status. We will also look at changes to fitness levels, physical and metabolic function and whether there is any change in mood or quality of life.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
23/WM/0201
Date of REC Opinion
5 Dec 2023
REC opinion
Further Information Favourable Opinion