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| Sponsor: | Aarhus University Hospital |
|---|---|
| Information provided by (Responsible Party): | University of Aarhus ( Aarhus University Hospital ) |
| ClinicalTrials.gov Identifier: | NCT00957294 |
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 |
| 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 |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lene Nyboe, PT, Msc | +45 77 89 35 73 | lenenyboe@ps.rm.dk |
| 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 | |
More Information
| 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 |
|
Schizophrenia Metabolic Syndrome X Schizophrenia and Disorders with Psychotic Features Mental Disorders |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |