Overview

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

Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Treatments:
Liraglutide
Metformin
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