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

Phase 4

Completed

• Conditions: Type 2 Diabetes; Overweight; Obesity
• Interventions: Drug: Metformin; Drug: Liraglutide

• Registration Number: NCT02014740
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Study Start: 2014-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2018-02-20
• Results First Submitted QC: 2018-03-21
• Results First Posted: 2018-03-22
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	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
Liraglutide	Liraglutide	• 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.
Liraglutide	Metformin	• 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.

Primary Outcome Measures

Name	Time	Method
Echocardiographic Epicardial Fat Thickness	6 months	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States