Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Schizophrenia |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 10 - 55 |
| Updated: | 6/21/2018 |
| Start Date: | August 2007 |
| End Date: | May 2012 |
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.
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.
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.
The inclusion criteria for the schizophrenia/schizoaffective group are: i) aged 18-55
years; ii) otherwise healthy and meets DSM-IV criteria for schizophrenia, any type, or
schizoaffective disorder iii) able to give informed consent.
The inclusion criteria for children are: i) age 10-18 years; ii) otherwise healthy and
meets DSM-IV criteria for one or more childhood-onset psychiatric disorder iii) able to
give assent and have a guardian able to provide informed consent.
The inclusion criteria for the healthy controls are: aged 18-55 years; ii) otherwise
healthy and do not meet DSM-IV criteria for any Axis I psychiatric illness; iii) able to
give informed consent.
The exclusion criteria are: i) Any lifetime DSM-IV diagnoses of intravenous drug use or
alcohol dependence, or if criteria for alcohol abuse were ever met, subject must have not
met criteria for abuse within the last 12 months; ii) any history of hepatitis; iii)
medications that can cause significant changes in hepatic function, glucose, or lipid
metabolism, as determined by the investigator; iv) lipid lowering or glucose lowering
medications; v) involuntary legal status (as per Missouri law); vi) pregnancy.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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