Prevention of Progression of Prediabetes, Obesity and CV Risk

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06446531
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Pre-Diabetes
  • Weight, Body

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Oral tablet administered once daily
  • Rybelsus Tablet — DRUG
    Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.
  • Jardiance 25Mg Tablet — DRUG
    Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily
  • 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)
  • Actos — DRUG
    Oral tablet dosed at 15mg once daily

Study Details

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.

Key Dates

Start date
Sep 11, 2024
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Hemoglobin A1c Level (HBA1c) [ Time Frame: Baseline and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Carolina Solis-Herrera, MD
[email protected]
210-567-4900

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University of Texas Health Science Center at San Antonio· San Antonio, TX

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