Prevention of Progression of Prediabetes, Obesity and CV Risk

Eligibility Criteria

• 1. Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the last 6 months.
• 2. Age ≥ 18 years old
• 3. Body Mass Index (BMI)=25-40 kg/m2
• 4. Glycated Hemoglobin (HbA1c) = 5.7-6.4%
• 5. Blood Pressure (BP) \<160/100
• 6. Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
• 7. Body weight must be stable (±5 pounds) over the last 3 months.
• 8. Oral diuretics, if prescribed to the patient according to local guidelines and discretion of the investigator, should be stable for at least 1 week prior to randomization.
• 9. Hispanic ethic group
• 10. Willing to adhere to medication regimen for up to 6 months.
• 11. Male or female, if female, met these criteria:
• 1. Not pregnant or breast-feeding
• 2. Negative pregnancy test result at visit 1 (screening)
• 3. During the entire study, women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or pills, or a vasectomized partner prior to receiving the first dose of study medication
• 12. Does not suffer from severe claustrophobia
• 13. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
• 1. Patients currently on one of the selected therapies
• 2. Extended diagnoses with Type 2 Diabetes
• 3. Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
• 4. Known allergy/sensitivity to study drugs or their ingredients
• 5. Major oncologic diagnosis in the last 5 years
• 6. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• 7. Inability or unwillingness of individual or legal guardian/representative to give written informed consent
• 8. Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
• 9. Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
• 10. Heart transplant recipient or listed for a heart transplant
• 11. Currently implanted left ventricular assist device
• 12. Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
• 13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
• 14. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization
• 15. Implanted cardioverter defibrillator within 3 months prior to screening
• 16. Cardiac resynchronization therapy