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Protocol
            
706771

Title
            
Inflammation and the metabolic syndrome in humans

Official Title
            
Inflammation and the Metabolic Syndrome in Humans (Version 6.2, dated 12/21/2006)

Investigator
            
Muredach Reilly, MB

Status
            
Recruiting

Why is this study being done?
            
People who are overweight are at increased risk of cardiovascular (heart) disease. Being overweight and having heart disease are linked in that both involve inflammation. Inflammation refers to the body’s first line of defense against infection and injury. Metabolic changes in 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 lead to heart disease.

Who is eligible to participate in this study?
            Inclusion
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?
            From:
18

What is involved with this study?
            
The screening visit (Visit 1) 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). Volunteers may also be asked to have an exercise stress test (also called a treadmill test), depending on the results from the screening visit.

The baseline visit (Visit 2) involves placement of two intravenous lines, administration of glucose and insulin (through the IV lines), diet instruction, a DEXA scan and a CT scan (both scans are similar to X Rays).

The inpatient visit (Visit 3) is an overnight stay of 3 nights and 2 days. During this time, two IV lines are placed, blood is drawn, urine is collected, vital signs are measured, 3 meals are provided daily and a questionnaire is given. In addition, on inpatient Day 2, we will give a low dose of LPS in order to learn more about the inflammatory effects that occur in people who are overweight. Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living) that can cause many of the effects similar to bacterial infections in humans. However, it can be administered in very small amounts to produce a mild inflammatory response much the same as a 'flu' like illness. The flu-like symptoms last about 6 to 8 hours and volunteers are closely monitored by study staff and physicians. On inpatient Day 3, we will repeat the test (originally done during the baseline visit) involving glucose and insulin administration, then the study is over and volunteers are discharged from the hospital.


How long will this study run?
            
Participation in this research study will last approximately 4-6 weeks and patients will need to visit the General Clinical Research Center (GCRC) approximately 3 times during the study. Three outpatient visits and one inpatient stay (2 days, 3 nights) at the Hospital of the University of Pennsylvania are required.

Who can I contact for additional information on this trial?
            Name:
Jennifer Tabita-Martinez, RN, MS
            Phone:
(215)615-3421
            Email:
jtabita@mail.med.upenn.edu