Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT02014740Other id20120811

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 100 participants (actual)
Sponsor: University of Miami · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Mar 2014
Primary completion: Mar 2017
Completion: Mar 2017
First posted: 18 Dec 2013 (estimated)
Last update posted: 6 Jun 2019
Conditions: Type 2 Diabetes · Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142015201620172018

Ph 4
Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes
NCT02014740
Mar 2014 to Mar 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LiraglutideDrug
MetforminDrug

Arms2

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.
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Echocardiographic Epicardial Fat Thickness
Time frame · 6 months
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

Echocardiographic Epicardial Fat Thickness

Group	Value (mm)	Spread
Liraglutide	9.6	2
Metformin	7.4	1.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LiraglutideL-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.	0 / 55	0 / 55	16 / 55
MetforminM-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 Metformin	0 / 45	0 / 45	12 / 45

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

3 results

Liraglutide causes large and rapid epicardial fat reduction.

Iacobellis et al. 2017Obesity (Silver Spring, Md.)cited by 202

PMID 28124506DOI 10.1002/oby.21718PUB-28124506

Full text at the publisher3 results

Publisher page See results (3)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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