Schizophrenia Clinical Trial
Official title:
Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients
Participants will be asked to do the following:
1. A screening session in which you will take part in a diagnostic interview that will take
about 2-3 hours to complete and will address your medical history. If you've recently
participated in one of Dr. Haupt's or Dr. Newcomer's studies (HRPO #03-1281, 01-0134, or
04-0191) you may not have to complete this screening interview.
2. An ultrasound test of your heart and blood vessels where an ultrasound machine will use
sound waves to create images that allow the main blood vessels in your neck to be
examined. You will be lying down for the procedure, and a colorless gel will be applied
to the side of your neck where the handheld probe (called a transducer) will be placed.
The transducer will then be gently moved over each side of your neck. This procedure
will take approximately 30 minutes.
3. A magnetic resonance image (MRI) study where the amount of fat in your liver will be
measured. The MRI involves having your body painlessly scanned inside a tubular machine,
while lying on a table for about 45 minutes.
4. Some routine blood tests to assess glucose (sugar) and lipid (fat) control and liver
function, as well as an additional hepatitis screen if you have a history of hepatitis.
You will go to the Intensive Research Unit (IRU) or Clinical Trials Unit (CTU) after an
8 to 10-hour overnight fast (except water). Approximately 42 ml (3 tablespoons) of blood
will be obtained from you, and you will also have your height, weight, blood pressure,
and waist and hip measurements taken. This will take approximately one hour.
5. A dual energy x-ray absorptiometry (DEXA) scan to measure your body fat and body muscle
content. The DEXA scan involves lying on a table in a private room wearing a hospital
gown for about 15 minutes while a machine silently measures the amount of fat in your
body. The DEXA scan is part of the research study and gives the researcher a picture of
how much fat is in your body.
In comparison to the general population, major mental illness is associated with higher rates of heart disease, stroke, and diabetes. These problems can result in a life span that can be up to 25 years shorter than in people without a major mental illness. This study uses established medical tests that can predict how you might be affected. The purpose of this study is to compare the risk for these disorders in people with schizophrenia with the risk for these disorders in other people without schizophrenia. ;
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