LXRA Gene Polymorphisms and Response to Fenofibrate

Study Overview
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Brief Summary
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This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. Genetics refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.

Detailed Description
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This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.

Official Title
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LXRA Gene Polymorphisms and Response to Fenofibrate

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fenofibrate capsule daily for 4 weeks
* Drug: Fenofibrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women) Must be able to swallow tablets Exclusion Criteria: Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20% Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-Fenofibrate then Placebo<br>4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo | Drug: Fenofibrate capsule daily for 4 weeks<br>* Placebo capsule daily for 4 weeks<br>Drug: Fenofibrate<br>* 160 mg/day orally for 4 weeks<br>|
| Active Comparator: 2 Placebo then Fenofibrate<br>4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. | Drug: Fenofibrate capsule daily for 4 weeks<br>* Placebo capsule daily for 4 weeks<br>Drug: Fenofibrate<br>* 160 mg/day orally for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log(ENA-Period 2 End/ENA Period 1 End) | Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects. Natural logs used | week 12 to week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers