Prevention of Progression of Prediabetes, Obesity and CV Risk

Korábbi kezelés

• Patients currently on one of the selected therapies
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• 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
• Implanted cardioverter defibrillator within 3 months prior to screening

Más betegség

• Extended diagnoses with Type 2 Diabetes
• Known allergy/sensitivity to study drugs or their ingredients
• Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
• Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
• Heart transplant recipient or listed for a heart transplant
• Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
• Cardiac resynchronization therapy

Életkor

• Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception

Egyéb

• Major oncologic diagnosis in the last 5 years
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent
• Currently implanted left ventricular assist device
• Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction

• 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.
• Age ≥ 18 years old
• Body Mass Index (BMI)=25-40 kg/m2
• Glycated Hemoglobin (HbA1c) = 5.7-6.4%
• Blood Pressure (BP) <160/100
• Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
• Body weight must be stable (±5 pounds) over the last 3 months.
• 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.
• Hispanic ethic group
• Willing to adhere to medication regimen for up to 6 months.
• Male or female, if female, met these criteria:
  • Not pregnant or breast-feeding
  • Negative pregnancy test result at visit 1 (screening)
  • 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
• Does not suffer from severe claustrophobia
• No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)