Cardiovascular Diseases, Pre-Diabetes, Weight, Body
Conditions
Keywords
Affordable strategies, Prevention of progression, Hispanic
Brief 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.
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.
Interventions
DRUGPlacebo
Oral tablet administered once daily
DRUGRybelsus Tablet
Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.
DRUGJardiance 25Mg Tablet
Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily
DRUGMetformin
Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)
DRUGActos
Oral tablet dosed at 15mg once daily
Sponsors
Baptist Health Foundation of San Antonio
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
Single-blind Randomized, placebo-controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c Level (HBA1c) | Baseline and 6 months | Percentage of glycated hemoglobin level in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Body Fat Composition | Baseline and 6 months | Measurement of body fat using a DEXA scan |
| Left Ventricular Function | Baseline and 6 months | Cardiac function is measured by left-ventricular function measured using cardiac MRI and expressed as a percentage |
| Measure of phosphocreatine k-value | Baseline and 6 months | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS |
| Body Mass Index (BMI) | Baseline and 6 months | Measure of body fat based on height and weight that applies to adult men and women |
| Measure of intramyocellular lipids (IMCL) | Baseline and 6 months | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS |
| Measure of extramyocellular lipids (EMCL) | Baseline and 6 months | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS |
| Patient Reported Outcomes (PROMIS) | Baseline and 6 months | A survey used to assess physical function. Subjects will rank 20 questions from a scale of 1 - 5, with 5 being the highest physical function and 1 being the lowest. The score will be added up, and the Raw score will be converted to T-Score using the PROMIS Adult v2.0 Physical Function 20a Short Form Conversion Table. The range of T-scores is 12.1-62.5. A higher score indicates higher physical function. |
| Measure of oxidative capacity | Baseline and 6 months | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS |
Countries
United States
Contacts
Primary ContactCarolina Solis-Herrera, MD
Backup ContactFrancisca Acosta, PhD
Outcome results
None listed