Description
Inclusion 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 β₯ 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) β₯30 ml/minβ’1.73m2
- 7. Body weight must be stable (Β±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)
Exclusion Criteria:
- 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
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No