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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014740
• Other study ID #: 20120811
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: June 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes

Intervention

Drug:
• Liraglutide
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. .
• Metformin

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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