Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics
The University of Texas Health Science Center at San Antonio
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.
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 group…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ≥ 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) ≥30 ml/min•1.73m2 7. Body weight must be stable (±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…
Interventions
- DrugPlacebo
Oral tablet administered once daily
- DrugRybelsus Tablet
Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.
- DrugJardiance 25Mg Tablet
Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily
- DrugMetformin
Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)
- DrugActos
Oral tablet dosed at 15mg once daily
Location
- University of Texas Health Science Center at San AntonioSan Antonio, Texas