Actively Recruiting
Prevention of Progression of Prediabetes, Obesity and CV Risk
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-11-12
64
Participants Needed
1
Research Sites
146 weeks
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
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.
CONDITIONS
Official Title
Prevention of Progression of Prediabetes, Obesity and CV Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with prediabetes within the last 6 months confirmed by acceptable tests
- Age 18 years or older
- Body Mass Index (BMI) between 25 and 40 kg/m2
- Hemoglobin A1c level between 5.7% and 6.4%
- Blood pressure below 160/100 mmHg
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73m2 or higher
- Body weight stable within plus or minus 15 pounds over the last 3 months
- Stable use of oral diuretics for at least 1 week before randomization if prescribed
- Self-identify as Hispanic
- Willing to follow the medication regimen for up to 6 months
- Male or female; if female, must not be pregnant or breastfeeding and have a negative pregnancy test at screening
- Women of childbearing potential must use effective birth control throughout the study
- No severe claustrophobia
- No contraindications to MRI such as metal implants or pacemaker
You will not qualify if you...
- Currently using any of the study's selected therapies
- Diagnosed with type 2 diabetes
- Pregnant, breastfeeding, or women of childbearing age unwilling to use contraception
- Allergic or sensitive to any study drugs or their ingredients
- Diagnosed with major cancer in the past 5 years
- Current drug or alcohol use or dependence that may affect study adherence
- Unable or unwilling to provide written informed consent
- Major organ or metabolic diseases or physical limitations preventing study completion
- Recent major cardiovascular events including heart attack or surgery within 60 days
- Heart transplant recipient or listed for transplant
- Implanted left ventricular assist device
- Certain types of cardiomyopathy or pericardial constriction
- Severe valvular heart disease expected to require surgery during the study
- Acute heart failure requiring intravenous treatments within 1 week before screening
- Implanted cardioverter defibrillator within 3 months prior to screening
- Cardiac resynchronization therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
F
Francisca Acosta, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here