Prevention of Progression of Prediabetes, Obesity and CV Risk

NCT06446531 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY00000485 Pre-DM
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Diabetes; Weight, Body; Cardiovascular Diseases

Keywords

Affordable strategies; Prevention of progression; Hispanic

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c Level (HBA1c)

  Percentage of glycated hemoglobin level in blood

  Baseline and 6 months

Secondary Outcomes (8)

• Body Mass Index (BMI)

  Baseline and 6 months

• Percentage of Body Fat Composition

  Baseline and 6 months

• Left Ventricular Function

  Baseline and 6 months

• Measure of phosphocreatine k-value

  Baseline and 6 months

• Measure of oxidative capacity

  Baseline and 6 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

SGLT2 inhibitor Group

EXPERIMENTAL

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

Drug: Jardiance 25Mg Tablet

GLP-1 Receptor Agonist Group

EXPERIMENTAL

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

Drug: Rybelsus Tablet

Metformin with SGLT2 Inhibitor Group

EXPERIMENTAL

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

Drug: Metformin; Drug: Actos

Interventions

Placebo DRUG

Oral tablet administered once daily

Also known as: Zebbo

Placebo

Rybelsus Tablet DRUG

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

Also known as: Semaglutide

GLP-1 Receptor Agonist Group

Jardiance 25Mg Tablet DRUG

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

Also known as: Empagliflozin

SGLT2 inhibitor Group

Metformin DRUG

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

Also known as: Metformin Hydrochloride

Metformin with SGLT2 Inhibitor Group

Actos DRUG

Oral tablet dosed at 15mg once daily

Also known as: Pioglitazone

Metformin with SGLT2 Inhibitor Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years old
• Body Mass Index (BMI)=25-40 kg/m2
• Glycated Hemoglobin (HbA1c) = 5.7-6.4%
• Blood Pressure (BP) \<160/100
• Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
• Body weight must be stable (±5 pounds) over the last 3 months.
• 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.
• Hispanic ethic group
• Willing to adhere to medication regimen for up to 6 months.
• Male or female, if female, met these criteria:
• Not pregnant or breast-feeding
• Negative pregnancy test result at visit 1 (screening)
• 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
• Does not suffer from severe claustrophobia

You may not qualify if:

• Patients currently on one of the selected therapies
• Extended diagnoses with Type 2 Diabetes
• Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
• Known allergy/sensitivity to study drugs or their ingredients
• Major oncologic diagnosis in the last 5 years
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent
• Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
• Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
• Heart transplant recipient or listed for a heart transplant
• Currently implanted left ventricular assist device
• Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
• Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
• 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
• Implanted cardioverter defibrillator within 3 months prior to screening

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Baptist Health Foundation of San Antonio: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Body Weight; Cardiovascular Diseases

Interventions

semaglutide; empagliflozin; Tablets; Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Carolina Solis-Herrera, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Solis-Herrera, MD

CONTACT

210-567-4900; solisherrera@uthscsa.edu

Francisca Acosta, PhD

CONTACT

acostafm@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind Randomized, placebo-controlled trial.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the time of publication in a peer review journal

Locations

US (1)