Affordable Treatments to Prevent Prediabetes, Obesity, and Heart Risk in Hispanic Adults

What this Trial Is About

Researchers are studying new and affordable treatments for people with prediabetes and obesity, aiming to bring blood sugar levels back to normal and help participants lose weight. The study also seeks to reduce the risk of heart problems by examining how these treatments affect metabolism and other body functions, potentially discovering new ways to treat diabetes and obesity in the future. Participants are randomly assigned to one of four groups for a 6-month treatment Nutritional Consultation plus either an SGLT2 inhibitor Empagliflozin, Rybelsus GLP-1 receptor agonist, Metformin combined with Pioglitazone, or a placebo. The treatments are given as oral tablets with specific dosing schedules, and the study does not require hospital overnight stays. During the study, participants will attend about 16 visits for evaluations including blood tests, body measurements, heart function assessments, and patient-reported outcomes. Researchers will measure hemoglobin A1c levels, body mass index, body fat percentage, and heart muscle function at the start and end of the 6 months. Participants will be monitored for safety and adherence throughout the study period, which lasts about 6 to 7 months in total.

Prevention of Progression of Prediabetes, Obesity and CV Risk