Impact of Empaglifozine on Cardiac Ectopic Fat

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Empagliflozin 10Mg Tab

• Registration Number: NCT03118336
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-06-16
• Primary Completion: 2019-02-07
• Status Verified: 2020-02
• Study Completion: 2020-02-07
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
empaglifozine group	Empagliflozin 10Mg Tab	-
placebo group	Empagliflozin 10Mg Tab	-

Primary Outcome Measures

Name	Time	Method
cardiac morphology	12 weeks	magnetic resonance imaging
epicardial adipose tissue volume	12weeks	magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
hepatic triglyceride content	12 weeks	proton magnetic resonance spectroscopy
myocardial PCr/ATP ratio	12 weeks
myocardial triglyceride	12weeks	proton magnetic resonance spectroscopy

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France