Predictors of Response to Fenofibrate (PreFar)

This study has been completed.
Sponsor:
Collaborators:
Tufts University
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01023750
First received: November 30, 2009
Last updated: November 22, 2013
Last verified: November 2013
  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: Observational
Study Design: Time Perspective: Prospective
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 ]

Enrollment: 39
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts 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:
  • Brand Name: TRICOR
  • NDC# 00074-6123-90

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who are seen in the UAB Diabetes and Endocrine Clinic or Cardiology Clinic

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023750

Locations
United States, Alabama
UAB Kirklin Clinic
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: 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: November 22, 2013
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 July 22, 2014