Fenofibrate and Pharmacogenetic Impact in Dyslipidemia

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: fenofibrate

• Registration Number: NCT00613613
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and FDA (Food and Drug Administration) approved medication for lowering triglycerides and cholesterol. The hypothesis: The pharmacogenetics of genes which affect drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the body) influences how a person responds to the lipid lowering medication-fenofibrate.

Detailed Description

The investigators seek to screen over 200 subjects for select candidate genes to serve as a source of subjects which may participate in a genotype guided investigation as to the predictability of response based on genotype. Response endpoints relate to lipid parameters and other variables of interest to cardiovascular endpoints. Subjects with genotypes of interest would then be enrolled into a short term clinical trial evaluating their response to fenofibrate based on their genetic profile ascertained from the screening phase.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 18-75 year old
• Be willing to participate in the study and attend the scheduled clinic exams
• Consent to taking lipid lowering therapy for 4 weeks and if necessary discontinue lipid lowering agents for a period of 8 weeks

Exclusion Criteria

• <18 years of age
• History of liver, kidney, pancreas, pancreatitis, gall bladder disease or malabsorption (Crohn's disease etc.)
• Use of insulin or currently taking warfarin
• Pregnant women or women of childbearing potential not using an acceptable form of contraception
• History of an allergy or hypersensitivity to fenofibrate
• Investigational drug use within 30 days of the study
• A disease that, in the opinion, of the PI, would put the subject at risk during the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	fenofibrate	High drug metabolism genotype All receive fenofibrate
2	fenofibrate	Low drug metabolism genotype All receive fenofibrate

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers	24 hours	We measured area under the curve (AUC) in mcg\*hr/mL (from time 0 to 24 hrs) at steady state for those of two specific genotypes for our UGT2B7 SNP following steady-state dosing of fenofibrate.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States