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Type 2 DiabetesPhase 3EMPACEFNCT03118336

Impact of Empaglifozine on Cardiac Ectopic Fat

A Phase 3 study testing Empagliflozin 10Mg Tab in people with Type 2 Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Empagliflozin 10Mg Tab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteFrance
Study dates
16 Jun 2017to 7 Feb 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Assistance Publique Hopitaux de Marseille

    Marseille

Other trials in France

About this study

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.

Conditions
Type 2 Diabetes
Being tested
Empagliflozin 10Mg Tab
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10Mg TabDrug

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

Study groups in NCT03118336
Study groupRoleWhat they receive
placebo groupPlacebo comparatorNot described
Receives: Drug: Empagliflozin 10Mg Tab
empaglifozine groupExperimentalNot described
Receives: Drug: Empagliflozin 10Mg Tab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiac morphology

    magnetic resonance imaging

    Measured: 12 weeks

  2. epicardial adipose tissue volume

    magnetic resonance imaging

    Measured: 12weeks

Secondary outcomes (3)

  1. myocardial triglyceride

    proton magnetic resonance spectroscopy

    Measured: 12weeks

  2. hepatic triglyceride content

    proton magnetic resonance spectroscopy

    Measured: 12 weeks

  3. myocardial PCr/ATP ratio

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start16 Jun 2017
  3. Primary completion7 Feb 2019
  4. Study completion7 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03118336
Sponsor's protocol ID
2016-39
Other IDs
2016-003196-21, 2016
Acronym
EMPACEF
Status last verified
Feb 2020
First submitted
13 Apr 2017
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37424866

  • 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.

    PubMed 33648515

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin 10Mg Tab in people with Type 2 Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiac morphology (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03118336, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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