DAMES study
Research type
Research Study
Full title
The role of sodium glucose co-transporter 2 inhibitors on metabolite utilisation in people with type 2 diabetes
IRAS ID
250375
Contact name
W. David Strain
Contact email
Sponsor organisation
University of Exeter
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Recent studies have shown that a group of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors have beneficial effects on the heart and kidneys, and this benefit is greater than other diabetes drugs. This benefit is unlikely to be due solely to improved blood sugar control, and may be due to the slight increase in ketones. Importantly, the small increase in ketones observed with these drugs is not harmful and may actually be of benefit as they can be used as an alternative fuel in preference to less efficient sources (e.g. fats and proteins). This shift to a more efficient fuel would make it easier for people to exercise, which might explain the improved heart function.
This study will examine how this drug works, specifically: 1) whether SGLT2 inhibitors enable individuals to use ketones as an energy source, and; 2) if this shift to a more efficient fuel increases exercise capacity.
Participants will visit the laboratory on 7 occasions over 8-9 months. Initially, we will assess the fuel used to provide energy at rest, and during exercise on a stationary bike, take blood and urine samples, and ask participants to walk as far as possible in 6 minutes. Participants will then take SGLT2 inhibitor (dapagliflozin) or dummy (placebo) tablets for 12 weeks, followed by a 6 week break, and then take the other set of tablets (dapagliflozin or placebo). Neither the participant nor the study team will know in which order they are given the tablets. Within the last two weeks of each treatment phase we will assess: 1) Energy use at rest and during exercise; 2) Physical activity and blood sugar levels; 3) the uptake of oxygen into the muscle from the blood; 4) blood and urine samples, and; 4) an optional muscle tissue sample.REC name
South West - Frenchay Research Ethics Committee
REC reference
19/SW/0187
Date of REC Opinion
31 Oct 2019
REC opinion
Further Information Favourable Opinion