Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®), on the fat surrounding the heart.Excessive amount of the fat around the heart is common in people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an injectable prescription medicine that can improve blood sugar control in adults with type 2 diabetes.

Official Title
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Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes

Conditions
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Type 2 Diabetes, Overweight, Obesity

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes, as defined by ADA criteria HbA1c < 8% measured at least 1 month prior to this study BMI ≥27 kg/m2 Pre-treatment with Metformin Age > 18 and < 65 years old Exclusion Criteria: • Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza® Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria Insulin dependent or treated type 2 diabetes Current use of other injectable incretins History of diabetes ketoacidosis Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2 Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure Clinical or laboratory evidences of chronic active liver diseases Acute or chronic infective diseases Cancer or chemotherapy Current use of systemic corticosteroids or in the 3 months prior this study Known or suspected allergy to Liraglutide, excipients, or related products Pregnant, breast-feeding or the intention of becoming pregnant Females of childbearing potential who are not using adequate contraceptive methods

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. | Drug: Liraglutide<br>* Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. .<br>Drug: Metformin<br> <br> |
| Active Comparator: Metformin<br>M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl | Drug: Metformin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic Epicardial Fat Thickness | Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epicardial fat, Type 2 diabetes, Obesity, GLP-1 analogs