Gustav Schonfeld, M.D. (Director)

DEPARTMENT OF Internal Medicine
Thomas G. Cole, Ph.D.; Anne C. Goldberg, M.D.; Jay W. Heinecke, M.D.; Elaine S. Krul, Ph.D.; Clay F. Semenkovich, M.D.
Keywords: lipid disorders, cell biology, clinical trials

In the Lipid Research Clinic, approximately 2,000 visits per year are made by private patients for the diagnosis and treatment of lipid disorders. An equal number of visits is made by patients enrolled in clinical protocols testing new lipid-lowering drugs for the pharmaceutical industry. The clinic also participated in the Lipid Research Clinics Coronary Primary Prevention Trial that established the efficacy of lowering plasma cholesterol in reducing coronary heart disease risk.

The Division of Atherosclerosis, Nutrition and Lipid Research of Washington University School of Medicine operates a core laboratory that supports clinical studies, drug trials and basic research. An extensive array of highly specialized lipid and routine clinical chemistry tests are performed in the lipid research core laboratory on private and study patients. The core laboratory also serves as a central laboratory for multi-center clinical trials on behalf of the pharmaceutical industry. Certified by the College of American Pathologies (CAP) and the World Health Organization, the core laboratory obtains external proficiency testing through the CAP and the lipid standardization program of the Centers for Disease Control and Prevention (CDC). As a member of the Cholesterol Reference Method Network Laboratory program of the CDC, the core laboratory internally monitors the accuracy of its own cholesterol measurements and evaluates the performance of clinical and reference laboratories.

The core laboratory is an active partner in clinical drug trials, providing high quality laboratory services to expedite FDA approval. It administers the entire process, from specimen collection through the reporting of results, providing all supplies to the clinical sites and instructing study coordinators. Immediate problem resolution is one of its major attributes; study samples are monitored upon receipt to identify any protocol violations.

Investigator-initiated basic and clinical research currently includes studies on the regulation of fatty acid synthetase and lipoprotein lipase gene expression, variant forms of ApoB, and the role of tyrosyl radicals in tissue damage and atherosclerosis. Techniques include molecular and cell biology, molecular genetics and in vivo studies in animals and humans.