NCT03118336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Jun 2017

Typical duration for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

April 13, 2017

Last Update Submit

February 13, 2020

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • cardiac morphology

    magnetic resonance imaging

    12 weeks

  • epicardial adipose tissue volume

    magnetic resonance imaging

    12weeks

Secondary Outcomes (3)

  • myocardial triglyceride

    12weeks

  • hepatic triglyceride content

    12 weeks

  • myocardial PCr/ATP ratio

    12 weeks

Study Arms (2)

placebo group

PLACEBO COMPARATOR
Drug: Empagliflozin 10Mg Tab

empaglifozine group

EXPERIMENTAL
Drug: Empagliflozin 10Mg Tab

Interventions

Empagliflozin 10Mg TabDRUG

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

empaglifozine groupplacebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

Related Publications (2)

  • Soghomonian A, Dutour A, Kachenoura N, Thuny F, Lasbleiz A, Ancel P, Cristofari R, Jouve E, Simeoni U, Kober F, Bernard M, Gaborit B. Is increased myocardial triglyceride content associated with early changes in left ventricular function? A 1H-MRS and MRI strain study. Front Endocrinol (Lausanne). 2023 Jun 22;14:1181452. doi: 10.3389/fendo.2023.1181452. eCollection 2023.

    PMID: 37424866DERIVED

  • Gaborit B, Ancel P, Abdullah AE, Maurice F, Abdesselam I, Calen A, Soghomonian A, Houssays M, Varlet I, Eisinger M, Lasbleiz A, Peiretti F, Bornet CE, Lefur Y, Pini L, Rapacchi S, Bernard M, Resseguier N, Darmon P, Kober F, Dutour A. Effect of empagliflozin on ectopic fat stores and myocardial energetics in type 2 diabetes: the EMPACEF study. Cardiovasc Diabetol. 2021 Mar 1;20(1):57. doi: 10.1186/s12933-021-01237-2.

    PMID: 33648515DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • anne dutour

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 18, 2017

Study Start

June 16, 2017

Primary Completion

February 7, 2019

Study Completion

February 7, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

FR(1)