Urinary Steroid Metabolites in Autism

Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01197131

Enrollment

160

Registered

2010-09-09

Start date

2010-09-30

Completion date

2019-04-30

Last updated

2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Autism Spectrum Disorder

Keywords

autism, autism spectrum disorder, steroids, steroid metabolites, urinary steroid metabolites, hormone formation, androgen precursor

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

Inclusion criteria

* Autism spectrum disorder * Age 5-15 years

Exclusion criteria

* Epilepsia * Psychotropic medication * other severe illness

Design outcomes

Primary

Measure	Time frame	Description
difference in hormone formation and androgen precursors	3 years	Calculation of hormone formation by comparison of urinary steroid metabolites

Secondary

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

Countries

Austria

Outcome results