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

Plain English Summary

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes is a Phase 4 clinical trial sponsored by The University of Texas Health Science Center, Houston studying PreDiabetes. This study tests how a drug called Semaglutide works in people with prediabetes. It is for Mexican-Americans aged 18 and older who are at high risk of developing type 2 diabetes. Participants will receive Semaglutide and undergo regular tests to monitor their response. Alternatives include lifestyle changes and other medications, but this study focuses on a specific drug's genetic impact. The trial aims to enroll 300 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are a Mexican-American aged 18 or older with prediabetes. You must also be at high risk for diabetes, meaning you are obese or have other metabolic issues. You cannot join if you have type 1 or type 2 diabetes, are pregnant or breastfeeding, or have certain medical conditions. You also cannot have taken specific diabetes medications in the last 3 months. This trial is studying PreDiabetes, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how well your body produces and responds to insulin, which are key indicators of how effectively the drug is working to manage your blood sugar. The specific primary outcome measures are: Mean change in beta cell responsivity (12 weeks); Insulin Sensitivity (12 weeks); Disposition Index (12 weeks); GLP-1-Induced Potentiation (12 weeks); Mean change in GLP-1 Area Under the Curve (AUC) (12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial is important because it aims to understand why some people respond better to GLP-1 drugs than others, which could lead to more personalized treatments for diabetes and related conditions. This research targets PreDiabetes, where improved treatment options are needed.

Investor Insight

This trial investigates a promising drug class (GLP-1 agonists) for a growing population, potentially paving the way for more targeted therapies and a larger market share in diabetes management. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if this trial is right for you and what the potential benefits and risks are. Participation involves taking Semaglutide and attending regular appointments for blood tests and check-ups over a period of time. You will be monitored for side effects and your response to the medication. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 300 participants

Interventions

• DRUG: Semaglutide — Glucagon-like Peptide 1 Receptor Agonist

Primary Outcomes

• Mean change in beta cell responsivity (12 weeks)
• Insulin Sensitivity (12 weeks)
• Disposition Index (12 weeks)
• GLP-1-Induced Potentiation (12 weeks)
• Mean change in GLP-1 Area Under the Curve (AUC) (12 weeks)

Secondary Outcomes

• Mean change in glucose Area Under the Curve (AUC) (12 weeks)
• Mean change in C-peptide Area Under the Curve (AUC) (12 weeks)
• Change in hemoglobin A1C (12 weeks)
• Mean change in insulin Area Under the Curve (AUC) (12 weeks)
• Creation of eQTL-based disease prediction models (5 years)

Full 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

Trial Locations

• UTHealth Clinical Research Unit (CRU) at UT Brownsville, Brownsville, Texas, United States

Frequently Asked Questions

Related Conditions

• Prediabetes
• Type 2 Diabetes
• Obesity
• Cardiovascular Disease
• Renal Disease
• Metabolic Syndrome
• Insulin Resistance
• Glucose Intolerance
• Hypertension
• Dyslipidemia

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