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Effect of Liraglutide on metabolism and function of the left ventricle in patients with type 2 diabetes and heart problems: study with RMN investigations

Effects of Liraglutide on left ventricular (LV) morphology, function and energy metabolism in patients with type 2 diabetes and heart failure : an in vivo cardiac Magnetic Resonance Imaging and 31P Spectroscopy study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001408-37-IT
Enrollment
Unknown
Registered
2012-04-10
Start date
2011-06-08
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients affected by type 2 diabetes and heart failure MedDRA version: 14.1 Level: HLT Classification code 10012654 Term: Diabetic complications cardiovascular System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: VICTOZA*SC 2PEN 3ML 6MG/ML Pharmaceutical Form: Solution for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Sponsors

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: - Age between 40-70 years - men with type 2 diabetes for at least 1 year - HbA1c> 7% but less than 10% for at least the last 6 months during treatment with metformin 2 g / day - Ejection Fraction =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Body mass index> 32 kg/m2 - autonomic neuropathy - Creatinine> 1.5 mg / dl - Any disease / condition that might interfere with the study - Unstable Angina - Arrhythmia - Patients on metabolic treatment (trimetazidine, acipimox, perhexeline, thyroid hormones) - Patients unable to attend the study or to undergo testing protocol (contraindications to MRI such as pacemakers, metal objects and non-removable) - Claustrophobia - Anterior myocardial infarction

Design outcomes

Primary

MeasureTime frame
Main Objective: verify the hypothesis whether the administration of Liraglutide is able not only to improve glycemic control but also energy metabolism and function of the left ventricle (LV) in patients with type 2 diabetes;Secondary Objective: to identify the pathogenic mechanisms responsible for the potential improvement of left ventricular function during treatment with liraglutide in patients with type 2 diabetes.;Primary end point(s): 20% increase in the ratio PCr / ATP ratio than in Liraglutide Glimepiride study obtained by magnetic resonance spectroscopy 31P.;Timepoint(s) of evaluation of this end point: 1 months, 4 months—

Secondary

MeasureTime frame
Secondary end point(s): 10% increase in ejection fraction compared with Liraglutide Glimepiride obtained by cine cardiac magnetic resonance imaging study.;Timepoint(s) of evaluation of this end point: 1 months, 4 months—

Countries

Italy

Contacts

Public ContactMedicina generale - indirizzo diab.

Fondazione San Raffaele del Monte Tabor

perseghin.gianluca@hsr.it02.26432614

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026