Urinary Steroid Metabolites in Autism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder

Conditions
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Autism, Autism Spectrum Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Autism spectrum disorder Age 5-15 years Exclusion Criteria: Epilepsia Psychotropic medication other severe illness

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| autistic boys<br>Boys with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician | |
| autistic girls<br>Girls with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician. | |
| control boys<br>Healthy boys, age 5-15 years, mental status assessed by Marburger Beurteilungsskala zum Asperger-Syndrome (MBAS). | |
| control girls<br>Healthy girls, age 5-15 years, mental status assessed by Marburger Beurteilungsskala zum Asperger Syndrome (MBAS). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in hormone formation and androgen precursors | Calculation of hormone formation by comparison of urinary steroid metabolites | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in hormone formation in gender and age | Hormone formation depends on age and gender and will be calculated by comparison of urinary steroid metabolites | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, autism spectrum disorder, steroids, steroid metabolites, urinary steroid metabolites, hormone formation, androgen precursor