Physiological Study of Human Cholesterol Metabolism and Excretion

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The underlying hypothesis is that whole body cholesterol - including cholesterol present in tissues that cannot be measured by standard blood tests - is related to heart disease risk. Endogenous cholesterol will be labeled with an intravenous infusion of one type of cholesterol tracer and dietary cholesterol will be labeled with another. These tracers will be used to measure how fast cholesterol is synthesized and excreted using mass spectrometry to distinguish the tracers. Data will be related to circulating biomarkers (blood tests) and to the thickness of the lining of the carotid artery. The effect of the drug ezetimibe on these processes will also be determined. Successful completion of this study will give us more knowledge about cholesterol metabolism that may be useful in designing new drugs and treatments for patients with heart disease, especially those that are already receiving maximum amounts of current medications.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Richard E. Ostlund Jr., MD
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Ezetimibe

Criteria

Inclusion Criteria:

• Aim II. 100 subjects aged 30-80 with stable medical and/or surgical illnesses.

• Aim III. 30 subjects age 18-80 with LDL cholesterol <190, fasting triglycerides<250 and stable medical or surgical illnesses.

Exclusion Criteria:

• Aim II. Subjects taking ezetimibe, bile acid sequestrants or with gastrointestinal or liver disease will be excluded since these may affect whole body cholesterol metabolism.

• Subjects with coronary heart disease or other medical illnesses will not be excluded if medically stable.

• Adults under age 30 and children will be excluded because in our current database there is no relation between carotid intima-media thickness and cardiovascular risk factors in this younger group.

• Aim III. Individuals have risk factors for coronary heart disease that mandate drug treatment according to the National Cholesterol Education Program guidelines will be excluded.