Fenofibrate and Pharmacogenetic Impact in Dyslipidemia (FPI)

University of Minnesota (UMN)

Status

Completed

Conditions

Dyslipidemia

Treatments

Drug: fenofibrate

Study type

Observational

Funder types

Other

Identifiers

NCT00613613

AHA Grant #0755839Z (Other Identifier)

0708M15441

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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