Status:
COMPLETED
Liraglutide Effects on Epicardial Fat Inflammatory Genes
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type2 Diabetes
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 developm...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03260881
Start Date
September 1 2018
End Date
September 5 2024
Last Update
July 8 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136