Liraglutide Effects on Epicardial Fat Inflammatory Genes
Type2 Diabetes, Coronary Artery Disease
About this trial
This is an interventional treatment trial for Type2 Diabetes focused on measuring Epicardial Fat
Eligibility Criteria
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)
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
L-group
D-group
• L-group will be started on liraglutide. Liraglutide will be started and administered for from a minimum of 4 weeks up to 12 weeks prior to CABG 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). The dose of 1.8 mg daily will be maintained until the end of the 12-week study. Other and current diabetes treatment will be continued
placebo will be administered in addition to current treatment prior to the CABG 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). D-group 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.