The Role of Epigenetic Modifications in Autism Spectrum Disorder
1 other identifier
observational
40
0 countries
N/A
Brief Summary
Autism Spectrum Disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive or stereotyped behaviors. According to the World Health Organization , the prevalence of Autism Spectrum Disorder is one person in 160.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Sep 2017
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 15, 2017
May 1, 2017
1 year
May 12, 2017
May 12, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
The difference of percentage of DNA methylation of Brain derived neurotrophic factor gene and glial fibrillary acidic protein gene between the two groups
Real Time Polymerase Chain Reaction
one year
The relation between the severity of autistic symptoms and percentage of Brain derived neurotrophic factor gene and glial fibrillary acidic protein gene methylation in Autism cases group
correlation test
one year
Study Arms (2)
Autism Cases
20 confirmed autism cases will be involved in this study. 1. The autism patients will be diagnosed according to:Gilliam Autism Rating Scale Arabic version: An assessment of the severity of autism using the Gilliam autism rating scale Arabic version: This test was used for diagnosis and assessment of the severity of autistic features for ages 3-22 years. It consists of 56 items, subdivided into 4 subscales: communication, social interaction, stereotyped behaviors, development and total score. 2. Fasting blood samples will be collected from autism children for DNA Methylation-and quantitative Real-time Polymerase Chain Reaction Analysis
Control
20 age-gender matched typical development children that will be assigned to the normal control group. 1. Control children will be examined by a psychiatrist to exclude any sub-clinical autistic features. 2. Fasting blood samples will be collected from control children for DNA Methylation-and quantitative Real-time Polymerase Chain Reaction Analysis
Interventions
Fasting blood samples will be collected from both autism and controls for DNA extraction. Peripheral blood (2ml) will be drawn from the cubital vein intoplastic syringes. Lymphocytes will be isolated from blood samples. We will examine the gene methylation in the peripheral blood lymphocytes of drug-naı¨ve autism patients and control subjects. DNA will be isolated from lymphocytes, purified and processed for bisulfate modification. Bisulfate treatment of genomic DNA will be performed using DNA methylation kit according to the manufacturer´ instructions. Bisulfite treatment of genomic DNA converts cytosine to uracil, but leaves methylated 5'Cytosines unchanged. Quantitative real time Polymerase chain reaction will be used to determine the DNA methylation status of the Brian derived neurotrophic factor and glia fibrillary acidic protein genes using primers specific to the human genes.
An assessment of the severity of autism using the Gilliam autism rating scale Arabic version: This test was used for diagnosis and assessment of the severity of autistic features for ages 3-22 years. It consists of 56 items, subdivided into 4 subscales: communication, social interaction, stereotyped behaviors, development and total score. The Arabic version has been validated with good reliability and validity and used in many studies before. The lower the scores are, the worse the condition is. The scale will be done by trained and certified psychologist. The protocol and informed consent for this study will be reviewed and approved by the ethics committee at the Faculty of Medicine, Assiut University, Egypt.
Eligibility Criteria
The children attending the pediatric clinic at Assiut University Hospital
You may qualify if:
- \- All enrolled children with Autism Spectrum Disorder will be:
- Exhibit symptoms within the typical triad of autistic traits: communication impairment, social deficits, and ritualistic interests.
- Drug-naïve.
- Children with Autism Spectrum Disorder and controls will be 2-6 years old.
You may not qualify if:
- The control subjects will also clinically examined by the psychiatrist to exclude any sub-clinical autistic features. Children with Autism Spectrum Disorder and controls will excluded from the study if
- They receive treatment for any reason.
- Endocrinological disease, mental retardation, communication disorder, psychotic disorder, attention deficit hyperactivity disorder and learning disorders seen in the children or their family members.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
Bahi A. Sustained lentiviral-mediated overexpression of microRNA124a in the dentate gyrus exacerbates anxiety- and autism-like behaviors associated with neonatal isolation in rats. Behav Brain Res. 2016 Sep 15;311:298-308. doi: 10.1016/j.bbr.2016.05.033. Epub 2016 May 17.
PMID: 27211062RESULTBhandari R, Kuhad A. Resveratrol suppresses neuroinflammation in the experimental paradigm of autism spectrum disorders. Neurochem Int. 2017 Feb;103:8-23. doi: 10.1016/j.neuint.2016.12.012. Epub 2016 Dec 23.
PMID: 28025035RESULTGladkevich A, Kauffman HF, Korf J. Lymphocytes as a neural probe: potential for studying psychiatric disorders. Prog Neuropsychopharmacol Biol Psychiatry. 2004 May;28(3):559-76. doi: 10.1016/j.pnpbp.2004.01.009.
PMID: 15093964RESULTPaternain L, Martisova E, Campion J, Martinez JA, Ramirez MJ, Milagro FI. Methyl donor supplementation in rats reverses the deleterious effect of maternal separation on depression-like behaviour. Behav Brain Res. 2016 Feb 15;299:51-8. doi: 10.1016/j.bbr.2015.11.031. Epub 2015 Nov 25.
PMID: 26628207RESULTVuong HE, Hsiao EY. Emerging Roles for the Gut Microbiome in Autism Spectrum Disorder. Biol Psychiatry. 2017 Mar 1;81(5):411-423. doi: 10.1016/j.biopsych.2016.08.024. Epub 2016 Aug 26.
PMID: 27773355RESULTWang J, Zou Q, Han R, Li Y, Wang Y. Serum levels of Glial fibrillary acidic protein in Chinese children with autism spectrum disorders. Int J Dev Neurosci. 2017 Apr;57:41-45. doi: 10.1016/j.ijdevneu.2017.01.004. Epub 2017 Jan 11.
PMID: 28088366RESULTNishimura K, Nakamura K, Anitha A, Yamada K, Tsujii M, Iwayama Y, Hattori E, Toyota T, Takei N, Miyachi T, Iwata Y, Suzuki K, Matsuzaki H, Kawai M, Sekine Y, Tsuchiya K, Sugihara G, Suda S, Ouchi Y, Sugiyama T, Yoshikawa T, Mori N. Genetic analyses of the brain-derived neurotrophic factor (BDNF) gene in autism. Biochem Biophys Res Commun. 2007 Apr 27;356(1):200-6. doi: 10.1016/j.bbrc.2007.02.135. Epub 2007 Mar 5.
PMID: 17349978RESULTFerreira MC, Dorboz I, Rodriguez D, Boespflug Tanguy O. Screening for GFAP rearrangements in a cohort of Alexander disease and undetermined leukoencephalopathy patients. Eur J Med Genet. 2015 Sep;58(9):466-70. doi: 10.1016/j.ejmg.2015.07.002. Epub 2015 Jul 21.
PMID: 26208460RESULTSamadi SA, McConkey R. The utility of the Gilliam autism rating scale for identifying Iranian children with autism. Disabil Rehabil. 2014;36(6):452-6. doi: 10.3109/09638288.2013.797514. Epub 2013 Jun 5.
PMID: 23738615RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
May 12, 2017
First Posted
May 15, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2018
Study Completion
March 1, 2019
Last Updated
May 15, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share