Physical Activity Clinical Trial
Official title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
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.
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.
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