Phase
Condition
Vascular Diseases
Diabetes (Pediatric)
Treatment
Actos
Rybelsus Tablet
Jardiance 25Mg Tablet
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before thescreening 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 anddiscretion of the investigator, should be stable for at least 1 week prior torandomization.
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) 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
Does not suffer from severe claustrophobia
No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws,shrapnel, pins, or cardiac pacemaker)
Exclusion
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 usecontraception
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 siteinvestigator, would interfere with adherence to study requirements
Inability or unwillingness of individual or legal guardian/representative to givewritten informed consent
Major organ or metabolic diseases, or physical limitations that will not allow thesubject to complete the study
Myocardial infraction, coronary artery bypass graft surgery, or other majorcardiovascular 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 obstructivecardiomyopathy or known pericardial constriction
Any severe (obstructive or regurgitant) valvular heart disease, expected to lead tosurgery during the trial period
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
Implanted cardioverter defibrillator within 3 months prior to screening
Cardiac resynchronization therapy
Study Design
Study Description
Connect with a study center
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
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