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临床试验/NCT01197131
NCT01197131Unknown不适用

Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder

Intersci Research Association, Austria1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
difference in hormone formation and androgen precursors

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Autism spectrum disorder
  • Age 5-15 years

排除标准

  • Epilepsia
  • Psychotropic medication
  • other severe illness

结局指标

主要结局

difference in hormone formation and androgen precursors

时间窗: 3 years

Calculation of hormone formation by comparison of urinary steroid metabolites

次要结局

  • difference in hormone formation in gender and age(3 years)

研究者

发起方
Intersci Research Association, Austria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kurz Johann MD

Medical Doctor,

Intersci Research Association, Austria

研究点 (1)

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