Metabolic Syndrome in Patients With First-episode Schizophrenia
The Metabolic Syndrome in Patients With First-episode Schizophrenia - Prognosis and Prediction.
1 other identifier
observational
203
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 3, 2009
CompletedFirst Posted
Study publicly available on registry
August 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedDecember 3, 2014
March 1, 2012
3.7 years
August 3, 2009
December 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
metabolic syndrome
1 year
Study Arms (3)
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)
Eligibility Criteria
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.
You may qualify if:
- Patients with ICD-10 diagnosed schizophrenia
You may not qualify if:
- Physical disability
- Pregnancy
- IQ\< 55
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Unit, Dep. Q of Affective Disorders, Aarhus University Hospital, Risskov
Aarhus, Risskov, 8240, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2009
First Posted
August 12, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
December 3, 2014
Record last verified: 2012-03