Predictors of Response to Fenofibrate

Study Overview
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Brief Summary
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Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.

Official Title
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Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy

Conditions
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Hypertriglyceridemia, Insulin Resistance

Intervention / Treatment
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* Drug: Fenofibrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years old or over dyslipidemic patients designated to receive fenofibrate by their attending physician. All patients will be seen at the UAB Diabetes and Endocrine Clinic or Cardiology Clinic. Women who are unable to have children because of surgery or other medical reason or are using an effective form of birth control before the study begins and agree to continue to use an effective form of birth control for 6 months after taking the study drug. Exclusion Criteria: Under 19 and/or not a Dyslipidemic patient or dyslipidemic but with a medical condition (e.g., liver or kidney disease) that warrants contraindication of fenofibrate. Women who are pregnant, nursing and women who, unless they are unable to have children because of surgery or other medical reason, have not been using an effective form of birth control before the study begins and/or are unwilling to use an effective form of birth control for 6 months after taking the study drug will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fenofibrate<br> | Drug: Fenofibrate<br>* Participants will give a baseline blood sample and begin the 4 week course of fenofibrate. Patients will be given a 33-day dose of 145 mg of fenofibrate to be taken by mouth once a day. All doses of fenofibrate will be purchased in one batch, prepared at the pharmacy under supervision. A study nurse will collect each patient's 33-day dose of fenofibrate from the pharmacy and dispense to the study participants in the clinics. Patients will be given instructions on how to take the medication and given a 24-hr phone number to call in case of questions or need for additional care. Each patient will receive a phone call at least 2 times during the course of the trial to monitor the progress. Our co-investigators, who are also physicians will be available in case a study participant needs additional care. If not available, study participants will be able to reach the cardiologist or endocrinologist on call through an additional phone number we will provide.<br>* Other names: NDC# 00074-6123-90;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting triglyceride concentrations |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipids and markers of insulin resistance |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertriglyceridemia, Triglycerides, HDL, Insulin resistance