Health TrialsbyHealthPanel

Prevention of Progression of Prediabetes, Obesity and CV Risk

ConditionsPre-DiabetesWeight, BodyCardiovascular Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

64 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: SGLT2 inhibitor GroupExperimental treatment 1 intervention
Group C: GLP-1 Receptor Agonist GroupExperimental treatment 1 intervention
Group D: Metformin with SGLT2 Inhibitor GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Hemoglobin A1c Level (HBA1c)

Percentage of glycated hemoglobin level in blood

Time frame
Baseline and 6 months

Secondary outcomes

1

Body Mass Index (BMI)

Measure of body fat based on height and weight that applies to adult men and women

Time frame
Baseline and 6 months
2

Percentage of Body Fat Composition

Measurement of body fat using a DEXA scan

Time frame
Baseline and 6 months
3

Left Ventricular Function

Cardiac function is measured by left-ventricular function measured using cardiac MRI and expressed as a percentage

Time frame
Baseline and 6 months
4

Measure of phosphocreatine k-value

A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS

Time frame
Baseline and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Baptist Health Foundation of San Antonio

Collaborator

Source ClinicalTrials.gov
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