NCT06446531 · The University of Texas Health Science Center at San Antonio
Prevention of Progression of Prediabetes, Obesity and CV Risk
(Pre-DM)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Age ≥ 18 years old
- Body Mass Index (BMI)=25-40 kg/m2
- Glycated Hemoglobin (HbA1c) = 5.7-6.4%
- Blood Pressure (BP) \<160/100
- Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
- Body weight must be stable (±5 pounds) over the last 3 months.
- 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.
- Hispanic ethic group
- Willing to adhere to medication regimen for up to 6 months.
- Male or female, if female, met these criteria:
- Not pregnant or breast-feeding
- Negative pregnancy test result at visit 1 (screening)
- 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
- Does not suffer from severe claustrophobia
- No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
Exclusion criteria
- Patients currently on one of the selected therapies
- Extended diagnoses with Type 2 Diabetes
- Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
- Known allergy/sensitivity to study drugs or their ingredients
- Major oncologic diagnosis in the last 5 years
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
- Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
- Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
- Heart transplant recipient or listed for a heart transplant
- Currently implanted left ventricular assist device
- Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
- Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
- 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
- Implanted cardioverter defibrillator within 3 months prior to screening
- Cardiac resynchronization therapy
Where
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2025 · Source of record for eligibility and locations