Influence of OCTN2 Variants on Carnitine Status and Plasma Triglycerides

This study is currently recruiting participants.

Verified by University of California, San Francisco, September 2005

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187733

Purpose

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. Previously, the investigators have recruited a cohort of healthy volunteers (Studies of Pharmacogenetics in Ethnically-Diverse Populations, or SOPHIE) and have resequenced the coding region of a number of membrane transporter genes to identify genetic polymorphisms in these genes. Subjects in this cohort have agreed to be called back for recruitment in further studies based on their own genetic sequence, allowing the investigators the possibility to prospectively study the influence of genetic polymorphisms on particular phenotypes (i.e., genotype-to-phenotype studies). The investigators plan to take a genotype-to-phenotype approach to study the influence of specific polymorphisms in the novel organic cation transporter 2 (OCTN2) gene on carnitine and lipid metabolism in healthy subjects.

Condition
Healthy

Drug Information available for: Carnitine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Prospective Study

Further study details as provided by University of California, San Francisco:

Estimated Enrollment:	16
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Previous participation in the "SOPHIE" study
Between the ages of 18 and 40 years old
Have a pre-selected genotype for OCTN1 and OCTN2
Have been selected as healthy by medical history questionnaire and screening blood work (complete blood count [CBC], comprehensive metabolic panel).

Exclusion Criteria:

Pregnant at the time of the study
Have a new history indicating they are no longer healthy
Taking a medication that could confound study results
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL).
Do not consent to participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187733

Contacts

Contact: Tom Urban, PharmD

415-476-6756

urbant@pharmacy.ucsf.edu

Locations

United States, California
San Francisco General Hospital	Recruiting
San Francisco, California, United States, 94143
Contact: Tom Urban, PharmD 415-476-6756 urbant@pharmacy.ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Kathleen Giacomini, PhD

University of California, San Francisco

More Information

Study ID Numbers:	1005
Study First Received:	September 14, 2005
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00187733
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

healthy volunteer

Study placed in the following topic categories:

Healthy
Carnitine

ClinicalTrials.gov processed this record on January 15, 2009