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โ† Trials
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Prevention of Progression of Prediabetes, Obesity and CV Risk

RecruitingPhase 1Ages 18 Years - anyAllThe University of Texas Health Science Center at โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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) โ‰ฅ30 ml/minโ€ข1.73m2 7. Body weight must be stable (ยฑ5 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
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What it tests

  • Placebo
  • Rybelsus Tablet
  • Jardiance 25Mg Tablet
  • Metformin
  • Actos
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Where

1 site
University of Texas Health Science Center at San Antonio
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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