Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT02751398|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : January 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Dapagliflozin 10mg Drug: Placebo 10mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Drug: Dapagliflozin 10mg
|Placebo Comparator: Placebo||
Drug: Placebo 10mg
Matching placebo for dapagliflozin 10 mg
- subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography [ Time Frame: 24-week ]
- the impact of dapagliflozin on patients' functional capacity [ Time Frame: 24-week ]functional capacity measured by maximum oxygen uptake (VO2max), Exercise time, Maximum exercise capacity (METs)
- the impact of dapagliflozin on resting diastolic function [ Time Frame: 24-week ]Diastolic function measured by LV mass index, Grade of diastolic function, Ea velocity, Left atrial volume index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751398
|Korea, Republic of|
|Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Geu-Ru Hong, MD, PhD 82-2-2228-8443 GRHONG@yuhs.ac|