LXRA Gene Polymorphisms and Response to Fenofibrate
Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Fenofibrate capsule daily for 4 weeks (Drug); Fenofibrate (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Florida Official(s) and/or principal investigator(s): Issam Zineh, PharmD, Principal Investigator, Affiliation: University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
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.
Clinical Details
Official title: LXRA Gene Polymorphisms and Response to Fenofibrate
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Log(ENA-Period 2 End/ENA Period 1 End)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Florida College of Pharmacy, Center for Pharmacogenomics, Gainesville, Florida 32610, United States
Additional Information
Starting date: March 2008
Last updated: May 24, 2012
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