Dapagliflozin during Exercise for the PrevenTion of Hypos (DEPTH)

• Research type

  Research Study

• Full title

  Dapagliflozin during exercise for the prevention of hypoglycaemia in Type 1 diabetes

• IRAS ID

  236006

• Contact name

  Ioannis Spiliotis

• Contact email

  ioannis.spiliotis@ocdem.ox.ac.uk

• Sponsor organisation

  University of Oxford

• Eudract number

  2017-003911-21

• Duration of Study in the UK

  0 years, 8 months, 19 days

• Research summary

  People with type 1 diabetes experience on average 2 episodes of significant low blood sugar (hypoglycemia) per week, and exercise (especially cardio-type) increases this risk. Strategies to prevent this include reducing the dose of insulin or eating more carbohydrates ("carb loading") before exercise, however it is difficult to get the balance right and overcompensation can lead to worsening of blood sugar control.
  Lay summary of study results: Cancelled Statement: The trial was halted due to the COVID-19 pandemic, and the decision was made not to restart it. A total of 9 participants were recruited, of whom 3 completed the trial. No results are available.
  URL to summary results: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkEPHC0LbJlX4PhbXmW-2Fy42SuiMpQ6PmHmsPb8GuSUlP1cOljqr7RQI53gbFPYNuog7mnRqRzD1GZe1Siyb9G48QeXWifa9P1tTB9bpUQ5-2B44PpnE_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81cCWcVOPD3WYRNUqoBMXZRGKXkpMlceUMT2Ecqh8sSLwZs2GrKS1CBuSW2j2Uf1-2FDDcwbc5SNA7Vdf9G6J4Q3tpeWSwzNrSkqy5OmeUbtWRfZZ-2BqEJFthHCX5PwwG6Uni00XuSiacWadeS4iJWPpK0ZLj884lVstRPLM79kGItlHw-3D-3D&data=05%7C02%7CTracy.Hamrang%40hra.nhs.uk%7Cd9e61732dd474a33c76008dca7021745%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638568874630920139%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=LcO7zuS4Xha%2FD78LHtR8tH6DKDWM9GKBEs1wNuqp4ok%3D&reserved=0

  The study we are proposing will be a clinical trial using dapagliflozin, a type of anti-diabetic medication already used in type 2 diabetes therapy, to test whether it can help prevent hypoglycaemia during and after exercise. Studies in mice and human cells from donors with and without diabetes have shown that this medication may have properties other than those it was originally used for, and it may be able to improve the way glucagon (a hormone that causes blood sugar to rise) is produced during hypoglycaemia.

  The aim of the clinical trial is to find out whether dapagliflozin can prevent or delay the development of hypoglycaemia during and up to 24h after exercise, and to investigate the changes in hormone levels. We will also look at the effect of dapagliflozin on overall blood sugar control during the trial.

  If our hypothesis is correct, those treated with dapagliflozin will be protected from developing exercise-induced hypoglycemia. This research will hopefully help people with type 1 diabetes lead a more active lifestyle in the future, while keeping their blood glucose levels in a safe range.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  18/SC/0137

• Date of REC Opinion

  20 Mar 2018

• REC opinion

  Favourable Opinion