Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients
Status:
Completed
Trial end date:
2020-06-15
Target enrollment:
Participant gender:
Summary
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.