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RECRUITING

NCT05119179

PHASE4

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2021-11-22

Completion Date

2026-10-31

Last Updated

2026-03-17

Healthy Volunteers

Conditions

PreDiabetes

Interventions

DRUG

Semaglutide

Glucagon-like Peptide 1 Receptor Agonist

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

Locations (1)

UTHealth Clinical Research Unit (CRU) at UT Brownsville

Brownsville, Texas, United States