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OpenTrials
Completed

NCT Number: NCT00957294

Metabolic Syndrome in Patients With First-episode Schizophrenia

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aarhus, Risskov, 8240, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ICD-10 diagnosed schizophrenia

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. metabolic syndrome

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

The Metabolic Syndrome in Patients With First-episode Schizophrenia - Prognosis and Prediction.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2009
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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