Impact of Empaglifozine on Cardiac Ectopic Fat

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-16

Study Completion Date

2020-02-07

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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo group

Group Type PLACEBO_COMPARATOR

Empagliflozin 10Mg Tab

Intervention Type DRUG

1 tablet of 10 milligrams per bone 1 time a day during 12 weeks

empaglifozine group

Group Type EXPERIMENTAL

Empagliflozin 10Mg Tab

Intervention Type DRUG

1 tablet of 10 milligrams per bone 1 time a day during 12 weeks

Interventions

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Empagliflozin 10Mg Tab

1 tablet of 10 milligrams per bone 1 time a day during 12 weeks

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No