Impact of Genetics on Metformin Pharmacokinetics

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:	NCT00187798

Purpose

Specific Aims: To compare metformin pharmacokinetics in monozygotic and dizygotic twin pairs. Comparing renal clearance of metformin in monozygotic and dizygotic twins will allow us to better understand the influence of heredity on variation in renal elimination. Furthermore, genotyping renal transporter genes in monozygotic and dizygotic twin pairs with significant differences in renal clearance of metformin may give us insight into the genes responsible for this variability.

Condition	Intervention
Healthy Volunteer	Drug: Metformin HCl

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Part of either a monozygotic or dizygotic twin pair.
Healthy (by medical history and laboratory values).
Between 18 and 40 years old.

Exclusion Criteria:

Taking regular medication other than vitamins.
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 Pregnant at time of study.
Diagnosis of hypoglycemia, phlebitis and/or stroke will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187798

Contacts

Contact: Chaline Brown, PharmD

415-476-6756

brownc@pharmacy.ucsf.edu

Locations

United States, California
University of California San Francsico	Recruiting
San Francisco, California, United States, 94143
Contact: Chaline Brown, PharmD 415-476-6756 brownc@pharmacy.ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Kathleen Giacomini, PhD

University of California San Francsico

More Information

Study ID Numbers:	928
Study First Received:	September 13, 2005
Last Updated:	September 15, 2005
ClinicalTrials.gov Identifier:	NCT00187798
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metformin
Healthy

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009