Metabolic Syndrome in Patients With First-episode Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier:
NCT00957294
First received: August 3, 2009
Last updated: March 20, 2012
Last verified: March 2012

August 3, 2009
March 20, 2012
August 2009
December 2012   (final data collection date for primary outcome measure)
metabolic syndrome [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00957294 on ClinicalTrials.gov Archive Site
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Metabolic Syndrome in Patients With First-episode Schizophrenia
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Metabolic Syndrome X
  • Schizophrenia
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patients with first-episode schizophrenia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with ICD-10 diagnosed schizophrenia

Exclusion Criteria:

  • Antipsychotic medication > 6 weeks before inclusion
  • Physical disability
  • Pregnancy
  • IQ< 55
Both
18 Years to 50 Years
No
Contact: Lene Nyboe, PT, Msc +45 77 89 35 73 lenenyboe@ps.rm.dk
Denmark
 
NCT00957294
Lene Nyboe Jacobsen
No
University of Aarhus ( Aarhus University Hospital )
Aarhus University Hospital
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University of Aarhus
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP