Metabolic Syndrome in Patients With First-episode Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Metabolic Syndrome X

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• Denmark
  • Risskov
    • Aarhus, Risskov, Denmark, 8240
      • Research Unit, Dep. Q of Affective Disorders, Aarhus University Hospital, Risskov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Patients with ICD-10 diagnosed schizophrenia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
metabolic syndrome	1 year

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 3, 2009
• First Submitted That Met QC Criteria: August 11, 2009
• First Posted (Estimate): August 12, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Schizophrenia Spectrum and Other Psychotic Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Schizophrenia; Metabolic Syndrome
• Other Study ID Numbers: Lene Nyboe Jacobsen