Ignite Creation Date:
2024-05-06 @ 10:28 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03260881
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2017-08-22
Brief Title:
Liraglutide Effects on Epicardial Fat Inflammatory Genes
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Effects of Liraglutide on Epicardial Fat Pro-Inflammatory Genes in Type 2 Diabetes and Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Epicardial adipose tissue EAT is the visceral fat of the heart EAT could locally affect the coronary arteries through local secretion of pro-inflammatory cytokines EAT plays a role in the development of the coronary artery disease CAD EAT is a highly enriched with genes involved in inflammation Given its rapid metabolism and simple measurability as first developed by Iacobellis EAT serves as target for medications targeting the fat Glucagon-like peptide-1 agonists GLP-1A are anti-diabetic medications with recently suggested cardio-protective properties Liraglutide a GLP-1A has recently shown to reduce the cardiovascular risk Iacobellisgroup found that EAT thickness decreased by an unprecedented 36 after 12 weeks of treatment with liraglutide Remarkably Iacobellisgroup found for the first time that human EAT express GLP-1 Receptor GLP-1R GLP-1A effects may be therefore visceral fat specific and target EAT Based on these preliminary data we hypothesize that treatment with liraglutide will significantly and rapidly reduce EAT inflammation Decreased EAT inflammation can reduce the burden of the coronary plaques We will test our hypothesis in a 12-week randomized double-blind placebo-controlled interventional study in 40 patients with type 2 diabetes mellitus T2DM and CAD with an acceptable glycemic control on their current diabetes regimen who require elective coronary artery bypass graft CABG regardless of their participation in the study A minimum time frame of 4-week treatment will be considered to detect significant changes in the study endpoints Inclusion criteria for body fat markers will rule out the confounding effect of different body fast distribution at baseline Study subjects will be randomized in two groups of 20 patients to receive additional liraglutide or to remain on current treatment placebo prior to cardiac surgery CAD subjects not allocated to liraglutide will be started on a supervised low calorie diet LCD to achieve approximately 5 of weight loss after from a minimum of 4 weeks up to 12 weeks to avoid the confounding effect of weight loss on the study outcomes EAT samples will be collected during cardiac surgery and processed for analysis of mRNA and protein expression of EAT inflammatory genes such as Tumor Necrosis Factor-alpha TNF-α and Interleukin 6 IL-6 and GLP-1R
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None