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Lay 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.

Category

  • Diabetes
  • Obesity
  • Heart, Vascular and Blood
IRB Number
STUDY00000485
NCT Number
NCT # not yet entered

Eligibility

Eligible Ages
18 years and older
Eligible Genders
All
Accepts Healthy Volunteers

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

Arm Groups

Study Contact

Francisca Acosta
210-562-4094
acostafm@uthscsa.edu

Francisca Acosta
acostafm@uthscsa.edu

Principal Investigator
Carolina Solis-Herrera