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

Plain-language summary

This study investigates how genetic characteristics relate to the response to Semaglutide, a GLP-1 medication, in Mexican-American people with prediabetes. It is enrolling people aged 18 and older who have prediabetes and are at high risk of progressing to diabetes. The study is in Phase 4 and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Recruiting

Sponsor

The University of Texas Health Science Center, Houston

Intervention

Semaglutide

Start date

11/22/2021

Estimated completion

10/31/2026

Countries

United States

Related genes

Locations

• Brownsville, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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