Pre-D will enroll 120 participants to receive one of four parallel group interventions for 13 weeks:
- dapagliflozin
- metformin
- physical activity (interval training, 5 days a week, 30 min per session) or
- control (lifestyle advice).
After the 13 weeks of intervention, a follow-up period of 13 weeks will follow to study the longer-term effects of the interventions.
Endpoint
The primary endpoint is reduction inglucose variability (measured by continuous glucose monitoring). Secondary endpoints include changes in various measures of glucose metabolism, body weight, cardiometabolic risk factors as well as objectively measured physical activity.
Collaborators
Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen
Links
Study protocol in BMJ Open