Urinary Steroid Metabolites in Autism

February 15, 2019 updated by: Kurz Johann MD, Intersci Research Association, Austria

Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Steiermark
      • Leibnitz, Steiermark, Austria, 8430
        • Intersci Research Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Autism spectrum disorder
  • Age 5-15 years

Exclusion Criteria:

  • Epilepsia
  • Psychotropic medication
  • other severe illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intersci Research Association, Austria

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol 1.0/18/06/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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