NCT06446531

Prevention of Progression of Prediabetes, Obesity and CV Risk

Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

While taking part in this study, participants will be asked to attend approximately 16 visits with the researchers or study staff. Study participants are assigned (single-blinded, only the study team will know the assigned group) to one of 4 study groups, receiving a 6-month treatment with Nutritional Consultation + either SGLT2 Inhibitor (Empagliflozin), Rybelsus (GLP1 Receptor Agonist), Metformin + Pioglitazone, or placebo. A placebo is an inactive, harmless substance that looks like the other study drugs. This study does not require overnight stays at the hospital in any of the study groups. Duration of the Study will be about 6-7 months.

Conditions

• Pre-Diabetes
• Weight, Body
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Placebo	Oral tablet administered once daily
DRUG	Rybelsus Tablet	Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.
DRUG	Jardiance 25Mg Tablet	Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily
DRUG	Metformin	Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)
DRUG	Actos	Oral tablet dosed at 15mg once daily

Timeline

• Start date: 2024-09-11
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-06-06
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study