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Prevention of Progression of Prediabetes, Obesity and CV Risk

NCT ID: NCT06446531

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-11

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Pre-Diabetes Weight, Body Cardiovascular Diseases

Keywords

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Affordable strategies Prevention of progression Hispanic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind Randomized, placebo-controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet administered once daily

SGLT2 inhibitor Group

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

Group Type EXPERIMENTAL

Jardiance 25Mg Tablet

Intervention Type DRUG

Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily

GLP-1 Receptor Agonist Group

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

Group Type EXPERIMENTAL

Rybelsus Tablet

Intervention Type DRUG

Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.

Metformin with SGLT2 Inhibitor Group

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)

Actos

Intervention Type DRUG

Oral tablet dosed at 15mg once daily

Interventions

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Placebo

Oral tablet administered once daily

Intervention Type DRUG

Rybelsus Tablet

Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.

Intervention Type DRUG

Jardiance 25Mg Tablet

Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily

Intervention Type DRUG

Metformin

Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)

Intervention Type DRUG

Actos

Oral tablet dosed at 15mg once daily

Intervention Type DRUG

Other Intervention Names

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Zebbo Semaglutide Empagliflozin Metformin Hydrochloride Pioglitazone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baptist Health Foundation of San Antonio

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolina Solis-Herrera, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carolina Solis-Herrera, MD

Role: CONTACT

Phone: 210-567-4900

Email: [email protected]

Francisca Acosta, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Carolina Solis-Herrera, MD

Role: primary

Other Identifiers

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STUDY00000485 Pre-DM

Identifier Type: -

Identifier Source: org_study_id