Prevention of Progression of Prediabetes, Obesity and CV Risk
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
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
Treatments tested in this trial
- Placebo
- Rybelsus Tablet
- Jardiance 25Mg Tablet
- Metformin
- Actos
Treatment groups
64 Participants
are divided into 4 treatment groupsSponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
Baptist Health Foundation of San Antonio
Collaborator
Source ClinicalTrials.gov