Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics
The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.
• 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)