Recruiting
Phase 1

Preventive Strategies

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06446531

Conditions

Pre-Diabetes

Weight, Body

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo

Rybelsus Tablet

Jardiance 25Mg Tablet

Metformin

Actos

Study Details

Brief 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.

Conditions

Pre-Diabetes

Weight, Body

Cardiovascular Diseases

Study ID

NCT06446531

Start date

Sep 11, 2024

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 prior to randomization.
9. Hispanic ethic group
10. Willing to adhere to medication regimen for up to 6 months.
11. Male or female, if female, met these criteria:

1. Not pregnant or breast-feeding
2. Negative pregnancy test result at visit 1 (screening)
3. During the entire study, women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or pills, or a vasectomized partner prior to receiving the first dose of study medication
12. Does not suffer from severe claustrophobia
13. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion Criteria:

1. Patients currently on one of the selected therapies
2. Extended diagnoses with Type 2 Diabetes
3. Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
4. Known allergy/sensitivity to study drugs or their ingredients
5. Major oncologic diagnosis in the last 5 years
6. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
7. Inability or unwillingness of individual or legal guardian/representative to give written informed consent
8. Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
9. Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
10. Heart transplant recipient or listed for a heart transplant
11. Currently implanted left ventricular assist device
12. Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
14. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization
15. Implanted cardioverter defibrillator within 3 months prior to screening
16. Cardiac resynchronization therapy

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Randomization will occur 1:1:1:1 to this placebo group

experimental: SGLT2 inhibitor Group

Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group

experimental: GLP-1 Receptor Agonist Group

Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group

experimental: Metformin with SGLT2 Inhibitor Group

Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group

Interventions

Placebo

Oral tablet administered once daily

Rybelsus Tablet

Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.

Jardiance 25Mg Tablet

Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily

Metformin

Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)

Actos

Oral tablet dosed at 15mg once daily

Primary outcome measure

  • Hemoglobin A1c Level (HBA1c) [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Carolina Solis-Herrera, MD

210-567-4900solisherrera@uthscsa.edu

Francisca Acosta, PhD

acostafm@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Carolina Solis-Herrera, MD

210-567-4900solisherrera@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • Affordable strategies
  • Prevention of progression
  • Hispanic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-11-12.