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Impact of Empaglifozine on Cardiac Ectopic Fat (EMPACEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118336
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Empagliflozin 10Mg Tab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Empaglifozine on Cardiac Ectopic Fat
Actual Study Start Date : June 16, 2017
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo group Drug: Empagliflozin 10Mg Tab
1 tablet of 10 milligrams per bone 1 time a day during 12 weeks

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




Primary Outcome Measures :
  1. cardiac morphology [ Time Frame: 12 weeks ]
    magnetic resonance imaging

  2. epicardial adipose tissue volume [ Time Frame: 12weeks ]
    magnetic resonance imaging


Secondary Outcome Measures :
  1. myocardial triglyceride [ Time Frame: 12weeks ]
    proton magnetic resonance spectroscopy

  2. hepatic triglyceride content [ Time Frame: 12 weeks ]
    proton magnetic resonance spectroscopy

  3. myocardial PCr/ATP ratio [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118336


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: anne dutour Assistance Publique Hopitaux De Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03118336    
Other Study ID Numbers: 2016-39
2016-003196-21 ( EudraCT Number )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs