Dapagliflozin Effects on Epicardial Fat
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|ClinicalTrials.gov Identifier: NCT02235298|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2014
Last Update Posted : September 7, 2020
Dapagliflozin is a new and emerging anti-diabetes medication. Dapagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is a consistent associated finding. Because dapagliflozin increases urinary glucose excretion, weight loss could result from reduced body fat secondary to caloric loss or from fluid loss secondary to osmotic diuresis or from a combination of both factors. Nevertheless, whether Dapaglifozin may cause a reduction in visceral fat is unknown.
Hence, in this study the investigators would like to test the hypothesis that Dapaglifozin causes a rapid and significant reduction of the epicardial fat, the visceral fat of the heart, in type 2 diabetic patients.
This hypothesis would be tested in a prospective interventional study in 100 overweight or obese type 2 diabetes subjects.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Dapagliflozin Drug: Metformin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Dapaglifozin will be administered the dose of 5 mg once daily. Metformin regimen will be continued.
Dapaglifozin causes a rapid and significant reduction of epicardial fat in type 2 diabetic patients
Active Comparator: Metformin
Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl.
- Epicardial fat Thickness [ Time Frame: 6 months ]Epicardial fat thickness will be measured with echocardiography according to the method described and validated by Iacobellis et al
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): NCT02235298
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|