Predictors of Response to Fenofibrate

Insulin Resistance Clinical Trial

— PreFar  

Official title:

Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023750
• Other study ID #: R21DK084560
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: October 11, 2015
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Insulin Resistance

Intervention

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.

Locations

Country	Name	City	State
United States	UAB Kirklin Clinic	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Tufts University, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting triglyceride concentrations		4 weeks	No
Secondary	Changes in lipids and markers of insulin resistance		4 weeks	No