Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients

Sponsor
Yonsei University
Study ID
NCT02751398
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2 DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients at resting diastolic function. This is single-center, randomized, double-blind, placebo-controlled, parallel-arm intervention study. This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction assessed. The dose of dapagliflozin will be 10 mg as approved. For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal exercise capacity were assessed before and after treatment. This study will be randomized, double blind, placebo controlled, to minimize the risk of bias.

Key Dates

Start date
Aug 18, 2016
Status verified
Aug 2020
Primary completion
Jun 15, 2020
Completion
Jun 15, 2020

Study Design

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

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10mg/day
  • Placebo Comparator: Placebo

Primary Outcome Measure

subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography [ Time Frame: 24-week ]

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