Prevention of Progression of Prediabetes, Obesity and CV Risk

Last updated: October 15, 2024
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Active - Recruiting

Phase

1

Condition

Vascular Diseases

Diabetes (Pediatric)

Treatment

Actos

Rybelsus Tablet

Jardiance 25Mg Tablet

Clinical Study ID

NCT06446531
STUDY00000485 Pre-DM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before thescreening 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 anddiscretion of the investigator, should be stable for at least 1 week prior torandomization.

  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:

  12. Not pregnant or breast-feeding

  13. Negative pregnancy test result at visit 1 (screening)

  14. During the entire study, women of childbearing potential (WOCBP) includingperi-menopausal women who have a menstrual period within 1 year must practiceappropriate, and effective birth control, either implants or pills, or avasectomized partner prior to receiving the first dose of study medication

  15. Does not suffer from severe claustrophobia

  16. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws,shrapnel, pins, or cardiac pacemaker)

Exclusion

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 usecontraception

  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 siteinvestigator, would interfere with adherence to study requirements

  7. Inability or unwillingness of individual or legal guardian/representative to givewritten informed consent

  8. Major organ or metabolic diseases, or physical limitations that will not allow thesubject to complete the study

  9. Myocardial infraction, coronary artery bypass graft surgery, or other majorcardiovascular 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 obstructivecardiomyopathy or known pericardial constriction

  13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead tosurgery 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 thescreening period prior to randomization

  15. Implanted cardioverter defibrillator within 3 months prior to screening

  16. Cardiac resynchronization therapy

Study Design

Total Participants: 64
Treatment Group(s): 5
Primary Treatment: Actos
Phase: 1
Study Start date:
September 11, 2024
Estimated Completion Date:
July 31, 2027

Study Description

While taking part in this study, participants will be asked to attend approximately 16 visits with the researchers or study staff.

Study participants are assigned (single-blinded, only the study team will know the assigned group) to one of 4 study groups, receiving a 6-month treatment with Nutritional Consultation + either SGLT2 Inhibitor (Empagliflozin), Rybelsus (GLP1 Receptor Agonist), Metformin + Pioglitazone, or placebo. A placebo is an inactive, harmless substance that looks like the other study drugs. This study does not require overnight stays at the hospital in any of the study groups.

Duration of the Study will be about 6-7 months.

Connect with a study center

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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