DETA
Impact of exercise training in combination with dapagliflozin on physical function in adults with type 2 diabetes mellitus: A randomised controlled trial
(Dapagliflozin,ExerciseTraining and physicAl function: the DETA trial)
Study Title
Background
Type 2 diabetes mellitus (T2DM), a disease characterised by high blood sugar levels, is also known to affect whole body health and fitness. As a result it can be thought of as a disease of accelerated ageing. This means that people with T2DM may find their physical health declines at an earlier age than someone without diabetes, making everyday activities harder. Being overweight and obese can make this even worse.
Several treatments for T2DM help with weight loss, with the potential to also improve overall physical health. Dapagliflozin is a type of medication called a sodium-glucose co-transporter 2 inhibitor (SGLT2i), which is widely used in routine clinical care. Dapagliflozin reduces blood sugar levels and also helps with weight loss.
However the extent to which dapagliflozin can also help improve overall physical health is not known.
Study Aims
To investigate whether dapagliflozin can be used to improve overall physical health, measured by how easy it is to undertake activities of daily living, and whether combining it with a programme of exercise can make the benefits even greater.
The study will also look at the effect of dapagliflozin with and without exercise on blood sugar levels, other blood markers of health and the heart’s pumping ability and overall heath.
Study Summary
This is a single centre, prospective, open-label, phase IV randomised controlled trial with follow up at 12 and 24 weeks. This means that 135 adults with T2DM and poor physical health will be randomly allocated to receive one of the following three treatments over 24 weeks:
Dapagliflozin: A daily tablet of dapagliflozin, in addition to their other normal medications.
Dapagliflozin and exercise: A daily tablet of dapagliflozin and participation in a structured exercise programme, supervised by a trained physiologist.
Diet control: Personalised support from a dietitian with the aim of losing the same amount of weight they would have if they were taking dapagliflozin (around 3 kg).
The main outcome will be how easily and quickly participants can perform activities of daily living, such as walking up stairs. Secondary outcomes include measures of diabetes control and other blood markers of health status. Participants will also be invited to undertake a scan of their heart to investigate the effect of the treatments on the heart’s overall health.
Study Progress
This study is due to enter the recruitment phase in May-June 2021.
Funding and Sponsorship
Funder: AstraZeneca plc.
Sponsor: University of Leicester
Study Publications
None yet
Research Team
Principle Investigator: Prof. Melanie Davies
Trial Manager: Dr. Nicole Coull
For more information about the DETA trial, please contact us on the below:
Phone: 0116 258 8897
Email: DETA@uhl-tr.nhs.uk or nicole.coull@uhl-tr.nhs.uk