AutismNCT01197131
Urinary Steroid Metabolites in Autism
An observational study of Autism and Autism Spectrum Disorder, run by Intersci Research Association, Austria at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2010to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children , age 5-15 years with autism and autism spectrum disorder resident in Austria without other severe or psychiatric disorders.
Who may be able to join
- Autism spectrum disorder
- Age 5-15 years
Who cannot join
- Epilepsia
- Psychotropic medication
- other severe illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, autism spectrum disorder, steroids, steroid metabolites, urinary steroid metabolites, hormone formation, androgen precursor
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
difference in hormone formation and androgen precursors
Calculation of hormone formation by comparison of urinary steroid metabolites
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersci Research Association, Austria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kurz Johann MD, Intersci Research Association, Austria
- Investigators
- Johann Kurz, MD, Principal investigator, Intersci Research Association, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197131
- Sponsor's protocol ID
- protocol 1.0/18/06/2010
- Status last verified
- Feb 2019
- First submitted
- 8 Sep 2010
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19492049Hu 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.
PubMed 19418574Purcell 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. doi: 10.1212/wnl.57.9.1618.
PubMed 11706102Geier 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.
PubMed 17984958
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01197131
- Acronym / sponsor ID
- protocol 1.0/18/06/2010
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, autism spectrum disorder, steroids, steroid metabolites, urinary steroid metabolites, hormone formation, androgen precursor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Intersci Research Association, AustriaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Apr 2019 (estimated)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children , age 5-15 years with autism and autism spectrum disorder resident in Austria without other severe or psychiatric disorders.
Key inclusion criteria (2 listed)
- Autism spectrum disorder
- Age 5-15 years
Key exclusion criteria (3 listed)
- Epilepsia
- Psychotropic medication
- other severe illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference in hormone formation and androgen precursors
Time frame: 3 years
Calculation of hormone formation by comparison of urinary steroid metabolites
1 secondary outcome
difference in hormone formation in gender and age
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background: PubMed 19492049Hu 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.
- Background: PubMed 19418574Hu 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.
- Background: PubMed 11706102Purcell 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. doi: 10.1212/wnl.57.9.1618.
- Background: PubMed 17984958Geier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Kurz, MD principal investigator
Intersci Research Association, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Autism Spectrum Disorder, run by Intersci Research Association, Austria at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in hormone formation and androgen precursors (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197131, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.