Metabolic parameters in paediatric patients with autism spectrum disorders (ASD) with and without antipsychotic medication. Prevalence, incidence and riskfactors.

In recent years there has been growing concern about metabolic adverse effects
of second- generation antipsychotics (SGAs). Although the risk of weight gain
due to use of SGAs has been well established, data on effects on metabolic
parameters remain very limited in paediatric patients (Almandil et al. 2013).
In paediatric patients with autism spectrum disorders (ASD), data on metabolic
parameters are even more limited. About the so-called first generation
antipsychotics (FGAs) are hardly any data available. Also, the relative
contribution of side-effects of antipsychotics and risk of an underlying
psychiatric illness, like an ASD itself for developing overweight and metabolic
abnormalities, remains unclear. International studies on the relationship of
overweight and ASD show contradictory results. It is unclear whether risk
factors for overweight are the same in ASD as for children and adolescents in
the general population. In The Netherlands, data on this subject are very
scarce.

To assess in paediatric patients with ASD with and without (first-time)
antipsychotic medication
• the prevalence and incidence of insulin resistance and other metabolic
abnormalities
• the risk factors for insulin resistance and other metabolic abnormalities

prospective observational follow-up design baseline and 6 months

Weight status of the paediatric patients with ASD and socio-demographic
characteristics are assigned according to standards of good clinical practice.
Laboratory assessments are also part of standard good clinical practice for
paediatric patients using antipsychotic medication. The extra burden will take
2 visits for the patient and his/her parents (90 min) , 2 blood draws by
venapuncture for the patients with ASD without antipsychotic medication (15 ml
each) and instruction and wearing of an actimeter. Besides that, the parents
and the child have to complete a number of questionnaires. Risks will be
negligible and physical discomfort mild. The research protocol includes the
participation of minors as antipsychotic medication is often prescribed on an
off-label basis to this vulnerable group, which warrants investigation.

Benefits of this study are:
• Metabolic abnormalities are found earlier during the study compared to the
clinical situation
• To our knowledge no (European) study has been performed in paediatric
patients with ASD with and without antipsychotic medication and metabolic
parameters
• This study provides clinicians with risk information regarding new
occurrences of metabolic disorders (including overweight) for prevention
purposes in paediatric patients with ASD. . As the study population is a
representative sample for Dutch paediatric patients diagnosed with ASD, results
can add information for the Dutch and international treatment guidelines.