Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Christopher Bell
Study ID
NCT02371187
Phase
PHASE2
Status
Completed

Conditions

  • Physical Activity

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Mar 2019
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dapagliflozin
    The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
  • Placebo Comparator: Placebo
    Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.

Primary Outcome Measure

Change From Baseline of Maximal Oxygen Uptake at Week 12 [ Time Frame: Baseline,12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Colorado State University, Dept. of Health and Exercise ScienceFort CollinsColorado80523-1582-

Find similar trials in Fort Collins, CO

By research site
Colorado State University, Dept. of Health and Exercise Science· Fort Collins, CO

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