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
  Purpose

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
Metabolic Syndrome X
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • metabolic syndrome [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with first-episode schizophrenia

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957294

Contacts
Contact: Lene Nyboe, PT, Msc +45 77 89 35 73 lenenyboe@ps.rm.dk

Locations
Denmark
Centre for Psychiatric Research, Aarhus University Hospital, Risskov Recruiting
Aarhus, Risskov, Denmark, 8240
Contact: Lene Nyboe, PT, Msc    +45 77 89 35 73    lenenyboe@ps.rm.dk   
Sponsors and Collaborators
Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier: NCT00957294     History of Changes
Other Study ID Numbers: Lene Nyboe Jacobsen
Study First Received: August 3, 2009
Last Updated: March 20, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on September 30, 2014