Trials / Completed
CompletedNCT03118336
Impact of Empaglifozine on Cardiac Ectopic Fat
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
There is substantial evidence supporting the fact that ectopic fat accumulation is an important contributor to type 2 diabetes complications and cardiovascular risk \[1\]. Epicardial adipose tissue (EAT), located between the myocardium and the visceral layer of the pericardium has been associated with atrial fibrillation and with coronary artery disease \[2, 3\] and its abundance predicts the number of cardiac events within 8 years \[4\]. In addition, myocardial steatosis has been shown to be an independent predictor of diastolic dysfunction \[5\] \[6\]. Furthermore, in type 2 diabetic patients, bariatric surgery can reduce cardiac ectopic fat accumulation and improve cardiac function \[7\] \[8\]. When added to standard care, 10 or 25 mg/d of empagliflozin, an inhibitor of sodium-glucose cotransporter 2 (iSGLT2), significantly reduces the risk of death, cardiovascular death, and hospitalisation for heart failure among individuals with type 2 diabetes and established cardiovascular disease when compared to placebo \[9\]. The mechanisms of empagliflozin-improved cardiovascular outcomes in type 2 diabetic patients at high risk of cardiovascular events are not known. We hypotheses that empaglifozin could modulate cardiac ectopic fat and cardiac metabolism in obese type 2 diabetic patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Empagliflozin 10Mg Tab | 1 tablet of 10 milligrams per bone 1 time a day during 12 weeks |
Timeline
- Start date
- 2017-06-16
- Primary completion
- 2019-02-07
- Completion
- 2020-02-07
- First posted
- 2017-04-18
- Last updated
- 2020-02-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03118336. Inclusion in this directory is not an endorsement.