title: Evaluation of the correlation between type 1 diabetes and cognitive function in children and adolescents, and comparison of this correlation with structural changes in the central nervous system: a study protocol.
abstract: BACKGROUND
  Diabetes mellitus type 1 (T1DM) affects nearly 15 million children worldwide and failure to achieve and maintain good glycaemic control in this group can lead to diabetes-related complications. Children with T1DM can experience impairment in cognitive function such as memory, attention and executive function. This study is designed to evaluate the correlation between diabetes and cognitive dysfunction as well as to clarify whether this correlation can be linked to neurological structural changes in 6-11-year-old children with diabetes.
  
  
  METHODS
  310 eligible children with diabetes will be divided into two groups based on glycaemic control according to their HbA1c index. The control group will include 150 children aged 6-11 without diabetes. The following parameters will be measured and investigated: duration of the disease since diagnosis, required daily insulin dose, frequency of insulin administration, hospital admissions due to diabetes, hypoglycaemic episodes during the last year, and episodes of diabetic ketoacidosis. The following components of cognitive function will be evaluated: memory, attention, executive function, decision-making and academic performance. Cognitive function and subsequent subtests will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) tools. Brain structural indices such as intracranial vault (ICV), as well as cerebrospinal fluid (CSF), ventricle, hippocampus, total intracranial, total brain, grey matter and white matter volume will be measured using MRI. ANOVA, correlational tests (Spearman) and regression models will be used to evaluate the hypothesis.
  
  
  BACKGROUND
  This study is approved by the ethics committee of the Endocrinology and Metabolism Research Institute (EMRI) of Tehran University of Medical Sciences (TUMS) under reference number 00300. Our findings are to be published in a peer-reviewed journal and disseminated both electronically and in print.
authors.affiliation: Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Ata
authors.initials: A
authors.lastname: Pourabbasi
authors.affiliation: Department of Psychiatry, Rouzbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Tehrani-Doost
authors.affiliation: Faculty of Psychology and Education, Allameh Tabataba'ee University, Tehran, Iran.
authors.forename: Soqra
authors.initials: S
authors.lastname: Ebrahimi Qavam
authors.affiliation: Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Bagher
authors.initials: B
authors.lastname: Larijani
mesh_terms: D001786:Blood Glucose; D001931:Brain Mapping; D016022:Case-Control Studies; D002648:Child; D003071:Cognition; D003072:Cognition Disorders / Q000000981:diagnostic imaging*; D048909:Diabetes Complications / Q000000981:diagnostic imaging; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000188:drug therapy; D056344:Executive Function; D005260:Female; D006801:Humans; D007328:Insulin / Q000008:administration & dosage; D007492:Iran; D008279:Magnetic Resonance Imaging; D008297:Male; D012044:Regression Analysis; D012107:Research Design; D012923:Social Class; D013647:Task Performance and Analysis
chemical_list: D001786:Blood Glucose; D007328:Insulin