Dapagliflozin Effects on Epicardial Fat

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT02235298
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.
  • Metformin — DRUG
    500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
  • Placebo — DRUG
    Placebo pill taken once daily to mimic Dapagliflozin

Study Details

The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.

Key Dates

Start date
Sep 30, 2015
Status verified
Jan 2021
Primary completion
Sep 10, 2020
Completion
Sep 10, 2020

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin and Metformin Group
    Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
  • Active Comparator: Metformin and Placebo Group
    Participants in this group will receive Metformin and Placebo for 6 months.

Primary Outcome Measure

Epicardial Fat Thickness [ Time Frame: At Baseline, 12 weeks, 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

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