Impact of Empaglifozine on Cardiac Ectopic Fat

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Empaglifozine on Cardiac Ectopic Fat

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Empagliflozin 10Mg Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years, Type 2 diabetes based on the disease diagnostic criteria as described by the WHO, HbA1c > 7% and < 10 % Stable glucose-lowering therapy for at least 3 weeks before randomization Estimated glomerular filtration rate > 60/ml (MDRD) Signed informed consent form obtained prior to any study procedure Exclusion Criteria: Evolutive or planned pregnancy during the six months Lactation Recent weight loss (>5% of body weight within one month), Treatment modifying adipose distribution such as corticoids Acute coronary syndrome or instable angina during the last 2 months, MRI contraindication (metal cardiac valve, pace maker, metal foreign body, claustrophobia)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br> | Drug: Empagliflozin 10Mg Tab<br>* 1 tablet of 10 milligrams per bone 1 time a day during 12 weeks<br>|
| Experimental: empaglifozine group<br> | Drug: Empagliflozin 10Mg Tab<br>* 1 tablet of 10 milligrams per bone 1 time a day during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac morphology | magnetic resonance imaging | 12 weeks | 
| epicardial adipose tissue volume | magnetic resonance imaging | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial triglyceride | proton magnetic resonance spectroscopy | 12weeks | 
| hepatic triglyceride content | proton magnetic resonance spectroscopy | 12 weeks | 
| myocardial PCr/ATP ratio |  | 12 weeks |