LXRA Gene Polymorphisms and Response to Fenofibrate

University of Florida

Status: Terminated

Conditions: Healthy

Treatments: Drug: Fenofibrate capsule daily for 4 weeks; Drug: Fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00644592

302-2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups

1-Fenofibrate then Placebo

Active Comparator group

Description:

4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo

Treatment:

Drug: Fenofibrate

Drug: Fenofibrate capsule daily for 4 weeks

2 Placebo then Fenofibrate

Active Comparator group

Description:

4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.

Treatment:

Drug: Fenofibrate

Drug: Fenofibrate capsule daily for 4 weeks