Impact of Empaglifozine on Cardiac Ectopic Fat

Sponsor
Assistance Publique Hopitaux De Marseille
Study ID
NCT03118336
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 16, 2017
Status verified
Feb 2020
Primary completion
Feb 7, 2019
Completion
Feb 7, 2020

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo group
  • Experimental: empaglifozine group

Primary Outcome Measure

cardiac morphology [ Time Frame: 12 weeks ]

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