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NCT03260881 · ClinicalTrials.gov registry record · Phase 4
Liraglutide Effects on Epicardial Fat Inflammatory Genes
A Phase 4 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT03260881 is a Phase 4 study that has completed, run by University of Miami. The registered enrollment target is 38 participants.
The verdict
NCT03260881, a Phase 4 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study 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. Iacobellis'group found that EAT thickness decreased by an unprecedented 36% after 12 weeks of treatment with liraglutide. Remarkably, Iacobellis'group 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 3-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
Interventions
- DRUG Liraglutide Pen Injector [Victoza]
- DRUG matching liraglutide-placebo pre-filled pens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2024-09-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03260881
The ClinicalTrials.gov registry entry for NCT03260881 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liraglutide Pen Injector [Victoza] is the first listed.
NCT03260881 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03260881 about?
NCT03260881 is a clinical study titled "Liraglutide Effects on Epicardial Fat Inflammatory Genes". 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 inflammati...
What is the current status of trial NCT03260881?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2018-09-01. Estimated completion is 2024-09-05.
What interventions are being tested in trial NCT03260881?
The interventions under investigation include: Liraglutide Pen Injector [Victoza] (DRUG), matching liraglutide-placebo pre-filled pens (DRUG).
Who is sponsoring clinical trial NCT03260881?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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