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Metabolic Syndrome in Patients With First-episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00957294
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible causes of developing metabolic syndrome. Several studies have investigated the metabolic side-effects of antipsychotic medication. However it is still unanswered how unhealthy lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study is to investigate the prevalence and development of MetS in first-episode patients with schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that physical inactivity, regardless of medication, is an independent risk factor for metabolic syndrome in patients with schizophrenia. In comparison inpatients with major depression and healthy controls, both matched on gender, age and level of education will be included in the study. It is anticipated that the study's results will provide new knowledge about the risk of developing metabolic syndrome in first-episode schizophrenia and how different risk factors contribute to this.

Condition or disease
Metabolic Syndrome X Schizophrenia

Study Design

Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Metabolic Syndrome in Patients With First-episode Schizophrenia - Prognosis and Prediction.
Study Start Date : August 2009
Primary Completion Date : April 2013
Study Completion Date : April 2013


Groups and Cohorts

Group/Cohort
Schizophrenia
Patients with first-episode schizophrenia age 18-45 years
Depression
First-time hospitalized patients with depression age 18-45 years
healthy controls
Healthy controls matched on age and gender (18-45 years)


Outcome Measures

Primary Outcome Measures :
  1. metabolic syndrome [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to The OPUS project, Region of Midtjylland, Denamrk In comparison in-patients with major depression, Aarhus University Hospital, Risskov and healthy controls matched on gender, age and level of education.
Criteria

Inclusion Criteria:

  • Patients with ICD-10 diagnosed schizophrenia

Exclusion Criteria:

  • Antipsychotic medication > 6 weeks before inclusion
  • Physical disability
  • Pregnancy
  • IQ< 55
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957294


Locations
Denmark
Research Unit, Dep. Q of Affective Disorders, Aarhus University Hospital, Risskov
Aarhus, Risskov, Denmark, 8240
Sponsors and Collaborators
Aarhus University Hospital
More Information

Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00957294     History of Changes
Other Study ID Numbers: Lene Nyboe Jacobsen
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: March 2012

Additional relevant MeSH terms:
Syndrome
Schizophrenia
Metabolic Syndrome X
Disease
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases