Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes; Overweight; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Intervention: Liraglutide; Metformin
Intervention description: 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. .
Intervention MeSH terms: Metformin; Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epicardial fat; Type 2 diabetes; Obesity; GLP-1 analogs

Summary:

      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.
    

Eligibility criteria:

        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