Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Christopher Bell
Study ID
NCT03180489
Phase
PHASE2
Status
Completed

Conditions

  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin Tablet — DRUG
    Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 Tablet — DRUG
    Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.

Study Details

Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose co-transporter 2 inhibitors 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. We wish to compare the health benefits of dietary counseling for weight loss with and without concomitant use of an SGLT2 inhibitor.

Key Dates

Start date
May 3, 2017
Status verified
Jan 2020
Primary completion
Dec 21, 2018
Completion
Dec 21, 2018

Study Design

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

Arms

  • Experimental: Dapagliflozin with dietary counseling
    Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss.
  • Placebo Comparator: Placebo with dietary counseling
    Daily oral administration of placebo tablet with dietary counseling to promote weight loss.

Primary Outcome Measure

Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test [ 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

Related Studies