A Phase 3 interventional study of Empagliflozin 10Mg Tab in Type 2 Diabetes, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 3, Interventional, and Treatment
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.
79 studies on the registry are indexed under Cardiac Complexes, Premature; 13 are open to participants now.
This study's enrollment of 56 is below the median of 86 across 40 interventional studies indexed under Cardiac Complexes, Premature.
Browse Cardiac Complexes, Premature studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Empagliflozin 10Mg Tab
Drug: Empagliflozin 10Mg Tab
1 tablet of 10 milligrams per bone 1 time a day during 12 weeks
cardiac morphology
magnetic resonance imaging
Time frame: 12 weeks
epicardial adipose tissue volume
magnetic resonance imaging
Time frame: 12weeks
myocardial triglyceride
proton magnetic resonance spectroscopy
Time frame: 12weeks
hepatic triglyceride content
proton magnetic resonance spectroscopy
Time frame: 12 weeks
myocardial PCr/ATP ratio
Time frame: 12 weeks
Plan to share: Undecided
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille