Predictors of Response to Fenofibrate (PreFar)
This study is currently recruiting participants.
Verified March 2012 by University of Alabama at Birmingham
Sponsor:
University of Alabama at Birmingham
Collaborators:
Tufts University
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Edmond Kabagambe, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01023750
First received: November 30, 2009
Last updated: March 21, 2012
Last verified: March 2012
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Purpose
Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertriglyceridemia Insulin Resistance |
Drug: Fenofibrate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy |
Resource links provided by NLM:
Further study details as provided by University of Alabama at Birmingham:
Primary Outcome Measures:
- Change in fasting triglyceride concentrations [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in lipids and markers of insulin resistance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Fenofibrate |
Drug: Fenofibrate
Participants will give a baseline blood sample and begin the 4 week course of fenofibrate. Patients will be given a 33-day dose of 145 mg of fenofibrate to be taken by mouth once a day. All doses of fenofibrate will be purchased in one batch, prepared at the pharmacy under supervision. A study nurse will collect each patient's 33-day dose of fenofibrate from the pharmacy and dispense to the study participants in the clinics. Patients will be given instructions on how to take the medication and given a 24-hr phone number to call in case of questions or need for additional care. Each patient will receive a phone call at least 2 times during the course of the trial to monitor the progress. Our co-investigators, who are also physicians will be available in case a study participant needs additional care. If not available, study participants will be able to reach the cardiologist or endocrinologist on call through an additional phone number we will provide.
Other Names:
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 19 years old or over dyslipidemic patients designated to receive fenofibrate by their attending physician.
- All patients will be seen at the UAB Diabetes and Endocrine Clinic or Cardiology Clinic.
- Women who are unable to have children because of surgery or other medical reason or are using an effective form of birth control before the study begins and agree to continue to use an effective form of birth control for 6 months after taking the study drug.
Exclusion Criteria:
- Under 19 and/or not a Dyslipidemic patient or dyslipidemic but with a medical condition (e.g., liver or kidney disease) that warrants contraindication of fenofibrate.
- Women who are pregnant, nursing and women who, unless they are unable to have children because of surgery or other medical reason, have not been using an effective form of birth control before the study begins and/or are unwilling to use an effective form of birth control for 6 months after taking the study drug will be excluded from the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023750
Contacts
| Contact: Edmond K Kabagambe, DVM, PhD | 205-934-2950 | edmondk@uab.edu |
| Contact: Carol E Mayes | 205-934-7155 | cmayes@uab.edu |
Locations
| United States, Alabama | |
| UAB Kirklin Clinic | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
Sponsors and Collaborators
University of Alabama at Birmingham
Tufts University
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Edmond K Kabagambe, DVM, PhD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | Edmond Kabagambe, Associate Professor of Public Health, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01023750 History of Changes |
| Other Study ID Numbers: | R21DK084560 |
| Study First Received: | November 30, 2009 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
hypertriglyceridemia Triglycerides HDL Insulin resistance |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Insulin Resistance Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hyperinsulinism Glucose Metabolism Disorders |
Fenofibrate Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013