Prevention of Progression of Prediabetes, Obesity and CV Risk (Pre-DM)

The University of Texas System (UT)

Status and phase: Enrolling; Phase 1

Conditions: Weight, Body; Cardiovascular Diseases; Pre-Diabetes

Treatments: Drug: Placebo; Drug: Metformin; Drug: Jardiance 25Mg Tablet; Drug: Rybelsus Tablet; Drug: Actos

Study type: Interventional

Funder types: Other

Identifiers

NCT06446531

STUDY00000485 Pre-DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Randomization will occur 1:1:1:1 to this placebo group

Treatment:

Drug: Placebo

SGLT2 inhibitor Group

Experimental group

Description:

Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group

Treatment:

Drug: Jardiance 25Mg Tablet

GLP-1 Receptor Agonist Group

Experimental group

Description:

Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group

Treatment:

Drug: Rybelsus Tablet

Metformin with SGLT2 Inhibitor Group

Experimental group

Description:

Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group

Treatment:

Drug: Actos

Drug: Metformin