Urinary Steroid Metabolites in Autism
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|ClinicalTrials.gov Identifier: NCT01197131|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : December 27, 2017
Deviation of hormone formation within nerve cells and nerve system provides autism spectrum disorder and neurodevelopment retardation through interaction of steroids with neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear steroid receptors.
Urinary steroid metabolites will be compared between children with autism spectrum disorder and healthy controls.
|Condition or disease|
|Autism Autism Spectrum Disorder|
Autism spectrum disorder presents many alterations in amino acid metabolism and in neurotransmitter systems (gamma amino acid system, glutamate-glutamine, nicotine-acid, serotonin-system) . Also alteration in gene activation within nerve cells and lymphocyte cultures encloses over 600 genes, affecting a wide field of enzymes , metabolic pathways and hormone formation. Male hormones and their precursors are often increased and their influence to nerve cell growth and spine formation is evident.
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.
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||March 2018|
Boys with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician
Girls with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician.
Healthy boys, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger-Syndrome" (MBAS).
Healthy girls, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger Syndrome" (MBAS).
- difference in hormone formation and androgen precursors [ Time Frame: 3 years ]Calculation of hormone formation by comparison of urinary steroid metabolites
- difference in hormone formation in gender and age [ Time Frame: 3 years ]Hormone formation depends on age and gender and will be calculated by comparison of urinary steroid metabolites
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197131
|Intersci Research Association|
|Leibnitz, Steiermark, Austria, 8430|
|Principal Investigator:||Johann Kurz, MD||Intersci Research Association, Austria|