Actively Recruiting
Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and Cardiovascular Risk in Hispanics
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-11-12
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
B
Baptist Health Foundation of San Antonio
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Prevention of Progression of Prediabetes, Obesity and CV Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of pre-Diabetes Mellitus documented within the last 6 months
- Age 18 years or older
- Body Mass Index (BMI) between 25 and 40 kg/m2
- Glycated Hemoglobin (HbA1c) between 5.7% and 6.4%
- Blood Pressure below 160/100
- Estimated Glomerular Filtration Rate (eGFR) of at least 30 ml/min/1.73m2
- Body weight stable within ±15 pounds over the last 3 months
- Stable use of oral diuretics for at least 1 week prior to randomization if prescribed
- Hispanic ethnicity
- Willingness to follow medication regimen for up to 6 months
- Female participants must not be pregnant or breastfeeding
- Negative pregnancy test at screening visit
- Women of childbearing potential must use effective birth control during the study
- No severe claustrophobia
- No contraindications for MRI such as metal implants or pacemakers
You will not qualify if you...
- Currently using one of the selected study therapies
- Diagnosis of Type 2 Diabetes
- Pregnancy, breastfeeding, or unwillingness to use contraception if of childbearing age
- Known allergy or sensitivity to study drugs or ingredients
- Major cancer diagnosis within the last 5 years
- Current drug or alcohol use interfering with study adherence
- Inability or unwillingness to provide informed consent
- Major organ or metabolic diseases or physical limitations preventing study completion
- Recent major cardiovascular events within 60 days
- Heart transplant recipient or listed for transplant
- Implanted left ventricular assist device
- Specific heart conditions including certain cardiomyopathies and severe valvular diseases
- Recent acute heart failure requiring intensive treatment
- Recent implanted cardioverter defibrillator within 3 months
- Cardiac resynchronization therapy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a 6-month treatment with Nutritional Consultation plus either SGLT2 Inhibitor (Empagliflozin), GLP-1 Receptor Agonist (Rybelsus), Metformin with Pioglitazone, or placebo.
Approximately 15 visits (in-person) during treatment
Trial Site Locations
Total: 1 location
1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
C
Carolina Solis-Herrera, MD
F
Francisca Acosta, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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