Prevention of Progression of Prediabetes, Obesity and CV Risk
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
πŸ—“οΈ Study Start (Actual) 1 July 2024
πŸ—“οΈ Primary Completion (Estimated) 1 July 2027
βœ… Study Completion (Estimated) 1 July 2027
πŸ‘₯ Enrollment (Estimated) 64
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE1
Locations:
πŸ“ San Antonio, Texas, United States

πŸ“‹ Eligibility Criteria

Description

    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 β‰₯ 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) β‰₯30 ml/minβ€’1.73m2
    • 7. Body weight must be stable (Β±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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 May 2024
  • First Submitted that Met QC Criteria 31 May 2024
  • First Posted 6 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 May 2024
  • Last Update Posted 6 June 2024
  • Last Verified May 2024