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:
3) physical activity (interval training, 5 days a week, 30 min per
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 primary endpoint
is reduction in glucose
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.
Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen
Study protocol in BMJ Open