Liraglutide Effects on Epicardial Fat Inflammatory Genes
- Status
- CompletedResults posted
- Why it is watched
- non-weight indication: inflammation, cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥10 required; non-obese participants included; conditions: Type2 Diabetes; Coronary Artery Disease
- Interventions
- Liraglutide Pen Injector [Victoza]; matching liraglutide-placebo pre-filled pens
- Conditions
- Type2 Diabetes; Coronary Artery Disease
- Phase and size
- Phase 4 · 38 participants
- Dates
- Start 2018-09-01
Primary completion 2024-09-05 - Sponsor
- University of Miami (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- EAT InflammationUp to 12 weeks
02Eligibility
Who can take part
Inclusion Criteria: * T2DM as defined by American Diabetes Association (ADA) criteria * Adult patients with T2DM who are indicated to receive liraglutide, not as first-line therapy, in addition to diet and exercise to improve glycemic control * Hemoglobin A1c (HbA1c) ≤ 9% * Age ≥ 18 years old * Body mass index (BMI) ≥ 27 Kg/m2 and/or waist circumference ≥ 102 cm (40 inches) in men and 88 cm (35 inches) in women, respectively. * Clinically and angiographically stable CAD who requires CABG as part of the standard medical care, as CAD does not represent a contraindication for using liraglutide. The stability of the CAD further warranties that study patients will not be exposed to higher risk by using liraglutide Exclusion Criteria: * Patients with a personal or family history of medullary thyroid carcinoma or patients with Multiple Endocrine Neoplasia syndrome type 2 * Patients with a prior serious hypersensitivity reaction to liraglutide * Other contra-indications to liraglutide in accordance with risks and safety information included in the latest updated prescribing information * Type 1 diabetes, as defined by ADA criteria * Current use of other GLP-1A, dipeptidyl peptidase 4 (DPP4) or Sodium Glucose transporters 2 (SGLT2) inhibitors, thiazolidinediones (TZDs), pramlintide and fixed prandial insulin. * Patients with unstable CAD, assessed by the Cardiology team and defined as new onset angina, rest angina, rapidly increasing or crescendo angina * History of diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; acute or chronic infective diseases, cancer or chemotherapy, history of pulmonary, renal or liver diseases, and drug abuse * Patients with chronic and acute inflammatory conditions such as sepsis, rheumatoid arthritis, ectopic dermatitis, asthma, ulcerative colitis. * Current use of systemic corticosteroids in the 3 months prior this study. * Pregnant or breast-feeding women * Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
03Change log
Registry changes
No changes recorded since the trial was added.