Prevention of Progression of Prediabetes, Obesity and CV Risk

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · May 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking for ways to help people with prediabetes and obesity, aiming to bring their blood sugar levels back to normal and support weight loss. The study also seeks to lower the risk of heart problems. Researchers will test new, affordable treatments and observe how these affect the body's metabolism and other functions, which could lead to better treatments for diabetes and obesity in the future.

To participate, individuals need to be at least 18 years old, have a body mass index (BMI) between 25 and 40, and have been diagnosed with prediabetes within the last six months. They should also be stable in their weight over the past three months and have certain health measurements within specific ranges. Participants will be asked to follow a medication plan for up to six months, and women of childbearing age must use effective birth control during the study. Those who qualify can expect regular check-ins and support throughout the trial as researchers work to find new ways to manage prediabetes and obesity effectively.

Gender

ALL

Eligibility criteria

• 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