Impact of Empaglifozine on Cardiac Ectopic Fat

Type 2 Diabetes Clinical Trial

— EMPACEF  

Official title:

Impact of Empaglifozine on Cardiac Ectopic Fat

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118336
• Other study ID #: 2016-39
• Secondary ID: 2016-003196-21
• Status: Completed
• Phase: Phase 3
• Start date: June 16, 2017
• Est. completion date: February 7, 2020

Study information

• Verified date: February 2020
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Empagliflozin 10Mg Tab
1 tablet of 10 milligrams per bone 1 time a day during 12 weeks

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac morphology	magnetic resonance imaging	12 weeks
Primary	epicardial adipose tissue volume	magnetic resonance imaging	12weeks
Secondary	myocardial triglyceride	proton magnetic resonance spectroscopy	12weeks
Secondary	hepatic triglyceride content	proton magnetic resonance spectroscopy	12 weeks
Secondary	myocardial PCr/ATP ratio		12 weeks