Effects of Antipsychotic Medications on Energy Intake and Expenditure
NCT ID: NCT00836251
Last Updated: 2014-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15 participants
OBSERVATIONAL
2006-04-30
2008-06-30
Brief Summary
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Aim 2: To evaluate the effect of antipsychotic treatment group on Energy Intake. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in EI over time than subjects treated with ziprasidone, based on higher histamine type 1 (H1) receptor affinity of olanzapine and the relationship between H1 affinity and hunger and/or satiety.
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Detailed Description
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Undesirable changes in body weight, blood sugar control, type 2 diabetes, and blood lipids occur more commonly in people who have schizophrenia than in people without psychiatric conditions. Although differences in glucose regulation were first reported in schizophrenia before the use of antipsychotic medications, antipsychotic treatment may contribute to these problems, though just how this happens is not understood. This study proposes to use a doubly-labeled water (DLW) method to measure the degree to which weight gain (fat mass) is due to increased appetite, decreased physical activity from being tired and sleepy, or some combination of both. Doubly-labeled water contains stable isotopes (non-radioactive forms) of the hydrogen and oxygen that make up all water, isotopes that will be slowly passed out through the urine after participants drink DLW. The number of hydrogen and oxygen isotopes found in the urine samples will tell us how many calories the participant's body has been using.
The DLW method has been used in people with obesity and other types of medical problems. It's recognized as the most accurate measure of the number of calories burned throughout a typical day, and how many calories are taken in from food and drink. By measuring these factors in people who take antipsychotic medications, doctors will gain a better understanding of the effects of antipsychotic medications on body weight and fat mass. This could lead to the development of better ways to prevent or treat weight gain or diabetes in patients who take antipsychotic medications.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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H218O and 2H2O
schizophrenia
H218O and 2H2O, administered as a mixed cocktail
0.195 g of H218O and 0.117 g of 2H2O per kg of estimated total body water (TBW), administered as a mixed cocktail
Interventions
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H218O and 2H2O, administered as a mixed cocktail
0.195 g of H218O and 0.117 g of 2H2O per kg of estimated total body water (TBW), administered as a mixed cocktail
Eligibility Criteria
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Inclusion Criteria
* schizophrenic or schizoaffective
* currently prescribed olanzapine or ziprasidone
* 18-80 y.o.
Exclusion Criteria
* diabetic
* not schizophrenic or schizoaffective
* not currently prescribed olanzapine or ziprasidone
18 Years
80 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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John W Newcomer, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Atlantic University
Ginger Nicol, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Other Identifiers
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06-0246
Identifier Type: -
Identifier Source: org_study_id
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