Pre-D trial

Prevention of type 2 diabetes and cardiovascular disease.

The Pre-D Trial is a randomised, controlled trial comparing the effects of metformin, SGLT2 inhibitors and exercise on glycaemic variability in individuals with prediabetes.

Pre-D will enroll 120 participants to receive one of four parallel group interventions for 13 weeks:
1) dapagliflozin
2) metformin
3) physical activity (interval training, 5 days a week, 30 min per session) or
4) 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.

The primary endpoint is reduction in glucose 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



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