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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10mg/day |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg | Drug |
| ||
| Placebo 10mg |
| Measure | Description | Time Frame |
|---|---|---|
| subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography | 24-week |
| Measure | Description | Time Frame |
|---|---|---|
| the impact of dapagliflozin on patients' functional capacity | functional capacity measured by maximum oxygen uptake (VO2max), Exercise time, Maximum exercise capacity (METs) | 24-week |
| the impact of dapagliflozin on resting diastolic function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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Matching placebo for dapagliflozin 10 mg |
|
Diastolic function measured by LV mass index, Grade of diastolic function, Ea velocity, Left atrial volume index
| 24-week |
| D004700 | Endocrine System Diseases |