Dapagliflozin, Exercise Training and physicAl function; the DETA trial
Research type
Research Study
Full title
Impact of exercise training in combination with dapagliflozin on physical function in adults with type 2 diabetes mellitus: A Randomised controlled trial
IRAS ID
276905
Contact name
Melanie Davies
Contact email
Sponsor organisation
University of Leicester
Eudract number
2019-004586-41
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
Type 2 diabetes mellitus (T2DM) increases metabolic ageing and physical deconditioning and this substantially increases the risk of having low physical function or developing physical frailty. Those with diabetes are up to five times more likely to be frail than individuals without diabetes. Frailty and the preceding ‘pre-frail’ state substantially and gradually increase the burden to patients (i.e. hospitalisation, institutionalisation and/or death) and economic burden of T2DM (i.e. health care expenditure). Therefore, there is an increasingly recognised need to quantify the effectiveness of management therapies on functional status in those with T2DM.
Since sodium-glucose co-transporter-2 inhibitors (SGLT2i) have been proven to cause weight loss, and there is data to suggest that they have a positive effect on whole body physiology, SGLT2i therapies have great potential in this area and are a good choice of therapy for investigation.
The aim of this study is to investigate the effects of exercise in individuals prescribed dapagliflozin for the management of T2DM, compared with diet and dapagliflozin alone, to see which is more effective at improving physical function. Participants will receive treatment (dapagliflozin alone, dapagliflozin + exercise or diet alone) for a period of 24 weeks.
Physical deconditioning will be assessed by a number of assessments, including blood tests, MRI and ECHO scans, skeletal muscle biopsy. Body composition will be assessed by measuring weight, waist circumference and body fat percentage (using DEXA). Energy expenditure and insulin sensitivity & secretion will be assessed using indirect calorimetry as well as physical activity measures. The modified physical performance test will measure physical function.
the main endpoint is the difference in the change of physical function between groups at 24 weeks.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0117
Date of REC Opinion
1 Jun 2020
REC opinion
Further Information Favourable Opinion