Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2010-09-30
2019-04-30
Brief Summary
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Urinary steroid metabolites will be compared between children with autism spectrum disorder and healthy controls.
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Detailed Description
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The diagnosis of autism spectrum disorder is made in accordance of criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) of the American Psychiatric Association by an experienced and specialised paediatrician or psychologist and /or by an Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule (ADOS) .
Overnight urine with measurement of quantity and time will be collected and a little part of the urinary samples will be frozen for storage till analysis. Age, weight and length of the children at collection time will be ascertained.
Four stratified groups (autistic boys, girls, and healthy controls, boys and girls, each age 5-15) will be formed.
Urinary samples will further remain anonymous through an Identification-Number (ID).
Analysis of hormones and the most of the known metabolites excreted in urine will be performed by a specialised laboratory using gas chromatography-mass spectrometry (GC/MS) analysis (University Hospital Bern, Steroid Laboratory, Switzerland).
The statistical analysis, with age, gender, weight, diagnosis and hormone analysis results as factors , consists in linear regression analysis to detect deviation in hormone formation and metabolism.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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autistic boys
Boys with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician
No interventions assigned to this group
autistic girls
Girls with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician.
No interventions assigned to this group
control boys
Healthy boys, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger-Syndrome" (MBAS).
No interventions assigned to this group
control girls
Healthy girls, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger Syndrome" (MBAS).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 5-15 years
Exclusion Criteria
* Psychotropic medication
* other severe illness
5 Years
15 Years
ALL
No
Sponsors
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Intersci Research Association, Austria
OTHER
Responsible Party
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Kurz Johann MD
Medical Doctor,
Principal Investigators
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Johann Kurz, MD
Role: PRINCIPAL_INVESTIGATOR
Intersci Research Association, Austria
Locations
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Intersci Research Association
Leibnitz, Styria, Styria, Austria
Countries
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References
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Hu VW, Nguyen A, Kim KS, Steinberg ME, Sarachana T, Scully MA, Soldin SJ, Luu T, Lee NH. Gene expression profiling of lymphoblasts from autistic and nonaffected sib pairs: altered pathways in neuronal development and steroid biosynthesis. PLoS One. 2009 Jun 3;4(6):e5775. doi: 10.1371/journal.pone.0005775.
Hu VW, Sarachana T, Kim KS, Nguyen A, Kulkarni S, Steinberg ME, Luu T, Lai Y, Lee NH. Gene expression profiling differentiates autism case-controls and phenotypic variants of autism spectrum disorders: evidence for circadian rhythm dysfunction in severe autism. Autism Res. 2009 Apr;2(2):78-97. doi: 10.1002/aur.73.
Purcell AE, Jeon OH, Zimmerman AW, Blue ME, Pevsner J. Postmortem brain abnormalities of the glutamate neurotransmitter system in autism. Neurology. 2001 Nov 13;57(9):1618-28. doi: 10.1212/wnl.57.9.1618.
Geier DA, Geier MR. A prospective assessment of androgen levels in patients with autistic spectrum disorders: biochemical underpinnings and suggested therapies. Neuro Endocrinol Lett. 2007 Oct;28(5):565-73.
Related Links
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Other Identifiers
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protocol 1.0/18/06/2010
Identifier Type: -
Identifier Source: org_study_id
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