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Pilot Study of Metabolic Effects of Low-Dose Endotoxemia

Official Title
A Pilot Study of Metabolic Effects of Low-Dose Endotoxemia(Clinical Protocol,Version date: July 17, 2006)

Muredach Reilly, MB


Why is this study being done?
Inflammation throughout the body is a common feature of obesity, diabetes and heart disease. Changes in metabolism of cholesterol, triglycerides (fat in the blood) and sugar in the blood caused by inflammation are similar to that in some people who are overweight. We wish to examine the effects of inflammation on these metabolic changes that may relate to heart disease.

Who is eligible to participate in this study?
We are looking for healthy volunteers who do not use tobacco products and are not taking any medications (birth control for females is acceptable).

Age range?

What is involved with this study?
The screening visit (Visit 1) lasts 3 hours and involves 2 blood draws, a urine collection, a physical exam, a test to measure percentage of body fat, drinking a sugar drink and an electrocardiogram (EKG).

If eligible according to screening results, the next 2 visits are 36 hour-long inpatient stays. During this time, two IV lines are placed, blood is drawn, urine is collected, several fat biopsies are taken, vital signs are measured, 3 meals are provided and questionnaires are given. Additionally, on inpatient Day 1, we will give a very low dose of a drug (LPS) or a placebo, in order to learn more about the inflammatory effects that occur in people who are overweight. On inpatient Day 2, we will do an IV glucose tolerance test involving glucose and insulin administration, then the study is over and volunteers are discharged from the hospital. The second inpatient visit occurs approximately one month after the first and follows the same procedures and timeline as the first inpatient stay.

Prior to each inpatient stay, participants will have a telephone consultation with a dietitian.

How long will this study run?
Patient participation in this research study will last approximately 2 months and patients will need to visit the General Clinical Research Center (GCRC) 3 times during the study.

Who can I contact for additional information on this trial?
Karen Terembula, RN, MS