LXRA Gene Polymorphisms and Response to Fenofibrate

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Drug: Fenofibrate capsule daily for 4 weeks; Drug: Fenofibrate

• Registration Number: NCT00644592
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-27
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2012-03-12
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-23
• Results First Posted: 2012-05-24
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1-Fenofibrate then Placebo	Fenofibrate capsule daily for 4 weeks	4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo
2 Placebo then Fenofibrate	Fenofibrate capsule daily for 4 weeks	4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
1-Fenofibrate then Placebo	Fenofibrate	4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo
2 Placebo then Fenofibrate	Fenofibrate	4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.

Primary Outcome Measures

Name	Time	Method
Log(ENA-Period 2 End/ENA Period 1 End)	week 12 to week 4	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

Trial Locations

Locations (1)

University of Florida College of Pharmacy, Center for Pharmacogenomics; 🇺🇸 Gainesville, Florida, United States