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Metabolic Syndrome in Patients With First-episode Schizophrenia

NCT ID: NCT00957294

Last Updated: 2014-12-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome X Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Schizophrenia

Patients with first-episode schizophrenia age 18-45 years

No interventions assigned to this group

Depression

First-time hospitalized patients with depression age 18-45 years

No interventions assigned to this group

healthy controls

Healthy controls matched on age and gender (18-45 years)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with ICD-10 diagnosed schizophrenia

Exclusion Criteria

* Antipsychotic medication \> 6 weeks before inclusion
* Physical disability
* Pregnancy
* IQ\< 55
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Unit, Dep. Q of Affective Disorders, Aarhus University Hospital, Risskov

Aarhus, Risskov, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Lene Nyboe Jacobsen

Identifier Type: -

Identifier Source: org_study_id