Metabolic parameters in paediatric patients with autism spectrum disorders (ASD) with and without antipsychotic medication. Prevalence, incidence and riskfactors.
Withdrawn
- Conditions
- autismriskfactor cardiovascular disease and diabetes100184241001256210018515
- Registration Number
- NL-OMON43968
- Lead Sponsor
- GGZ Centraal (Amersfoort)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 112
Inclusion Criteria
Paediatric patients aged between 6 and 18 years with a DSM- IV-TR diagnosis of ASD with and without an indication for treatment with antipsychotic medication. Co-medication like stimulants or SSRI*s is allowed. Patients on antipsychotic medication will start with this medication and have to be antipsychotic-naïve.
Exclusion Criteria
• History of treatment with antipsychotic medication (ASD group without antipsychotic medication)
• Treatment with more than 1 SGA
• Active or past eating disorder
• Biochemical evidence of thyroid dysfunction/diabetes mellitus.
• Pregnancy or breastfeeding
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Insulin resistance (HOMA2-IR)<br /><br><br /><br><br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>Fasting glucose, HbA1c<br /><br>Fasting trygliceriden<br /><br>HDL, LDL en total cholesterol<br /><br>Insulin<br /><br>Prolactin<br /><br>Testosteron (boys) Oestradiol (girls)<br /><br>Weight<br /><br>Height<br /><br>BMI and BMI z-score<br /><br>Fat percentage<br /><br>Bloodpressure and heart rate<br /><br>Haircortisol<br /><br><br /><br>Effectscales<br /><br>• Aberrant Behavior Checklist Irritability subscale (Aman 1985)<br /><br>• Clinical Global Impression improvement scale (Guy, 1976)<br /><br>• Social responsiveness scale (Constantino, 2003)<br /><br>• Repetitive behaviour Scale-R (Lam 2007)<br /><br><br /><br>Pubertal stage (Tanner)<br /><br>Questionnaire of fysical activity/eating behaviour<br /><br>Level of activity measured bij an actigraph (GENEActiv®)<br /><br>Ethnicity (country of birth both parents)<br /><br>Socio-economic status (Education level both parents)<br /><br>Weight status of both parents (BMI). </p><br>