Healthy
Conditions
Keywords
Healthy Volunteers
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.
Interventions
DRUGFenofibrate capsule daily for 4 weeks
Placebo capsule daily for 4 weeks
DRUGFenofibrate
160 mg/day orally for 4 weeks
Sponsors
American College of Clinical Pharmacy
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
UF Clinical Research Center. Started March 2008, completed August 2009.
Pre-assignment details
Patients were screened for eligibility.
Participants by arm
| Arm | Count |
|---|---|
| 1-Fenofibrate Then Placebo 4 weeks of drug at 160 mg orally per day | 5 |
| 2 Placebo Then Fenofibrate 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. | 6 |
| Total | 11 |
Baseline characteristics
| Characteristic | 2 Placebo Then Fenofibrate | 1-Fenofibrate Then Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Age Continuous | 26.0 years STANDARD_DEVIATION 6.6 | 29.2 years STANDARD_DEVIATION 17.1 | 27.5 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 11 | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
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
Time frame: week 12 to week 4
Population: Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-Fenofibrate Then Placebo | Log(ENA-Period 2 End/ENA Period 1 End) | -0.298 Log of Ratio | Standard Deviation 0.31 |
| 2 Placebo Then Fenofibrate | Log(ENA-Period 2 End/ENA Period 1 End) | 0.178 Log of Ratio | Standard Deviation 0.22 |
Comparison: This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.p-value: 0.01595% CI: [1.06, 1.52]t-test, 2 sided