Urinary Steroid Metabolites in Autism

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kurz Johann MD, Intersci Research Association, Austria
ClinicalTrials.gov Identifier:
NCT01197131
First received: September 8, 2010
Last updated: September 1, 2014
Last verified: September 2014
  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:


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

Primary Outcome Measures:
  • difference in hormone formation and androgen precursors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: March 2015
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

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
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
Study First Received: September 8, 2010
Last Updated: September 1, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Intersci Research Association, Austria:
autism
autism spectrum disorder
steroids
steroid metabolites
urinary steroid metabolites
hormone formation
androgen precursor

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014