NCT02371187

Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Christopher Bell · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Exercise is frequently prescribed as a favorable lifestyle intervention to prevent/reverse type 2 diabetes. It is also prescribed in addition to concurrent pharmacological treatment, such as metformin. Recent data (animal and human) suggest that metformin may attenuate the favorable benefits of exercise training. In light of the physiological mechanism of Dapagliflozin (sodium-glucose co-transporter 2 (SGLT2) inhibition), one might speculate that rather than inhibit, it will augment the favorable adaptations to exercise training.

Detailed description

This is a randomized, placebo-controlled, double blind, repeated measures study. 30 sedentary adults will be recruited for participation and randomly assigned to one of two 12-week treatments: 1) supervised endurance exercise training 4 days per week plus daily oral administration of Dapagliflozin; 2) supervised endurance exercise training 4 days per week plus daily oral administration of placebo. Prior to and following completion of the treatment the following dependent variables will be quantified: a) maximal aerobic capacity; b) substrate utilization during standardized low-moderate intensity exercise; c) skeletal muscle aerobic enzyme activity; d) body composition; and, e) oral glucose tolerance, fasting glucose and insulin resistance. The dose of Dapagliflozin will begin as 5 mg/day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to 10 mg/day for the remainder of the study.

Conditions

• Physical Activity

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
DRUG	Placebo	Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2015-02-25
• Last updated: 2019-04-10
• Results posted: 2019-04-10

Locations

1 site across 1 country: United States