Urinary Steroid Metabolites in Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01197131
• Other study ID #: protocol 1.0/18/06/2010
• Status: Active, not recruiting
• Start date: September 2010
• Est. completion date: April 2019

Study information

• Verified date: February 2019
• Source: Intersci Research Association, Austria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: April 2019
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Autism spectrum disorder

• Age 5-15 years

Exclusion Criteria:

• Epilepsia

• Psychotropic medication

• other severe illness

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
Austria	Intersci Research Association	Leibnitz	Steiermark

Sponsors (1)

Lead Sponsor	Collaborator
Intersci Research Association, Austria

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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