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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Gianluca Iacobellis, University of Miami
ClinicalTrials.gov Identifier:
NCT02014740
First received: December 12, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Overweight
Obesity
Drug: Liraglutide
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Echocardiographic epicardial fat thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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. .
Drug: Metformin
Active Comparator: 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
Drug: Metformin

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014740

Contacts
Contact: Gianluca Iacobellis, MD PhD giacobellis@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Gianluca Iacobellis, MD PhD       giacobellis@med.miami.edu   
Principal Investigator: Gianluca Iacobellis, MD PhD         
Sponsors and Collaborators
University of Miami
  More Information

No publications provided

Responsible Party: Gianluca Iacobellis, Professor of Clinical Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT02014740     History of Changes
Other Study ID Numbers: 20120811
Study First Received: December 12, 2013
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Epicardial fat
Type 2 diabetes
Obesity
GLP-1 analogs

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Overweight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Liraglutide
Metformin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014