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Urinary Steroid Metabolites in Autism

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01197131

First Posted: September 9, 2010

Last Update Posted: July 18, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Kurz Johann MD, Intersci Research Association, Austria

Purpose

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
Autism Autism Spectrum Disorder


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: autism spectrum disorder

MedlinePlus related topics: Autism Spectrum Disorder Hormones

U.S. FDA Resources

Further study details as provided by Kurz Johann MD, Intersci Research Association, Austria:

Primary Outcome Measures:

difference in hormone formation and androgen precursors [ Time Frame: 3 years ]
Calculation of hormone formation by comparison of urinary steroid metabolites

Secondary Outcome Measures:

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

noninvasive overnight urine (morning urine)


Enrollment:	160
Study Start Date:	September 2010
Estimated Study Completion Date:	October 2017
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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
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.
control boys Healthy boys, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger-Syndrome" (MBAS).
control girls Healthy girls, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger Syndrome" (MBAS).

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	5 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children , age 5-15 years with autism and autism spectrum disorder resident in Austria without other severe or psychiatric disorders.

Criteria

Inclusion Criteria:

Autism spectrum disorder
Age 5-15 years

Exclusion Criteria:

Epilepsia
Psychotropic medication
other severe illness

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Austria
Intersci Research Association
Leibnitz, Steiermark, Austria, 8430

Sponsors and Collaborators

Intersci Research Association, Austria

Investigators


Principal Investigator:	Johann Kurz, MD	Intersci Research Association, Austria

More Information

Publications:

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.

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.


Responsible Party:	Kurz Johann MD, Medical Doctor,, Intersci Research Association, Austria
ClinicalTrials.gov Identifier:	NCT01197131 History of Changes
Other Study ID Numbers:	protocol 1.0/18/06/2010
First Submitted:	September 8, 2010
First Posted:	September 9, 2010
Last Update Posted:	July 18, 2017
Last Verified:	July 2017

Keywords provided by Kurz Johann MD, Intersci Research Association, Austria:


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

Additional relevant MeSH terms:


Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders

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