NCT05119179 Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes
| NCT ID | NCT05119179 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-11-22 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2021-11-22 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project uses both transcriptomic- and genomic-level data to identify mechanisms of individual responses to glucagon-like peptide-1 (GLP-1) in Mexican-Americans with prediabetes. The GLP-1 hormone is essential for glucose reduction, weight loss, cardiovascular risk reduction, and renal protection. Newly discovered mechanisms will illuminate causal links between disease genotype and phenotype, which may ultimately guide personalized therapeutic approaches for type 2 diabetes, prediabetes, obesity, cardiovascular disease, renal disease, and other related diseases.
Eligibility Criteria
Inclusion criteria: 1. Men and women, ages 18 years and older 2. Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or a hemoglobin A1C ranging from 5.7% to 6.4% 3. High risk for progression to diabetes: defined as having at least one of the two following additional factors: Obesity (BMI ≥ 30 kg/m2) and/or metabolically unhealthy status. "Metabolically unhealthy status" is defined as at least two of the following: elevated blood pressure (SBP ≥ 130 mmHg and/or DBP ≥ 85 mmHg), elevated triglycerides ≥ 150 mg/dL, low HDL cholesterol (males \< 40 mg/dL; females \< 50 mg/dL), and elevated fasting glucose ≥ 100 mg/dL (Wu S et al., 2017). 4. Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, hormonal contraception, intrauterine contraception, or surgical sterilization) for the duration of the study. 5. Patients must have the following laboratory values: Hematocrit ≥ 34 vol%, estimated glomerular filtration rate ≥ 60 mL/min per 1.73 m2, AST (SGOT) \< 2.5 times ULN, ALT (SGPT) \< 2.5 times ULN, alkaline phosphatase \< 2.5 times ULN Exclusion Criteria: 1. History of Type 1 or Type 2 diabetes mellitus 2. Pregnant or breastfeeding women 3. Medications: metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, insulin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, and/or corticosteroids over the last 3 months. 4. Active malignancy 5. History of clinically significant cardiac, hepatic, pancreatic or renal disease. 6. History of any serious hypersensitivity reaction to the study medication (or any other incretin mimetic) 7. Prisoners or subjects who are involuntarily incarcerated 8. Prior history of pancreatitis, medullary thyroid cancer, or multiple endocrine neoplasia type 2 (MEN 2) 9. Family history of medullary thyroid cancer (a rare form of thyroid cancer) or MEN2. However, as many individuals may not be aware of the specific type of thyroid cancer, will also exclude any family history of thyroid cancer or MEN2. 10. Hospitalization for COVID-19 in last 3 months
Contact & Investigator
Absalon D Gutierrez, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05119179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05119179 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05119179 currently recruiting?
Yes, NCT05119179 is actively recruiting participants. Contact the research team at Norma.P.PerezOlazaran@uth.tmc.edu for enrollment information.
Where is the NCT05119179 trial being conducted?
This trial is being conducted at Brownsville, United States.
Who is sponsoring the NCT05119179 clinical trial?
NCT05119179 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Absalon D Gutierrez, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 300 participants.
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