Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Christopher Bell
Study ID
NCT02520518
Phase
PHASE2
Status
Terminated

Conditions

  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
  • Placebo — DRUG
  • Weight maintenance — BEHAVIORAL
  • Ad libitum dietary intake — BEHAVIORAL
  • Dietary restriction — BEHAVIORAL

Study Details

Th mechanism of action of dapagliflozin is via sodium-glucose co-transporter 2 (SGLT2) inhibition. Sodium-glucose co-transporter 2 inhibition is associated with moderate weight (fat) loss, in addition to other health benefits, including decreased blood pressure, decreased inflammation, and decreased oxidative stress. It is unclear as to whether these health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss.

Key Dates

Start date
Aug 31, 2015
Status verified
Dec 2018
Primary completion
May 31, 2017
Completion
May 31, 2017

Study Design

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

Arms

  • Experimental: Dapagliflozin: ad libitum dietary intake
    Daily oral administration of dapagliflozin with ad libitum dietary intake. 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.
  • Experimental: Dapagliflozin: weight maintenance
    Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. 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: ad libitum dietary intake
    Daily oral administration of a placebo with ad-libitum dietary intake. 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.
  • Placebo Comparator: Placebo: dietary restriction
    Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. 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 in Insulin Sensitivity 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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