Prevention of Progression of Prediabetes, Obesity and CV Risk
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Single-blind Randomized, placebo-controlled trial.
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- This will be single blind study, given all treatment arms being pills, once subjects are randomized, they will not be told which mediation they are taking, and treatment will be dispensed in unmarked bottles at each timepoint.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Randomization will occur 1:1:1:1 to this placebo group |
|
|
Experimental SGLT2 inhibitor Group |
Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group |
|
|
Experimental GLP-1 Receptor Agonist Group |
Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group |
|
|
Experimental Metformin with SGLT2 Inhibitor Group |
Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group |
|
Recruiting Locations
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
Detailed 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.