Clinical trial NCT02377583: Hypothalamo-pituitary Adrenal Axis Activity and Neuropsychological Consequences in Type 1 Diabetes in Childhood
Official title: Hypothalamo-pituitary Adrenal Axis Activity: Relation With Neuropsychological Consequences in Type 1 Diabetes in Childhood. The CORTICODIAB Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Age: The investigators will limit the study to children at least 6 years, to ensure the successful completion of saliva samples and MRI without anesthesia. The investigators limit themselves to prepubescent children do not have to take into account the influence of sex steroids on the AC activity.
* Gender: Although it is expected differences in hippocampal volume and CA activity between boys and girls, the relationship between these two variables is not necessarily different for boys and girls. Thus, the inclusion of both sexes in the analysis is not necessarily problematic, and will be more informative. So it has been finally decided to include boys and girls in the sample of subjects undergoing MRI.
* Population control: The constitution of a control group from the siblings will enable to study the specific effect of diabetes on anxiety and depression, regardless of the children's education mode in the same family environment.

Brief summary: The general objective is to precise the role of HPA axis activity in neuropsychological consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA axis is associated with higher scores of depression and changes in hippocampal volume and mean diffusion.

Detailed description: * Background: Type 1 diabetes could be associated with hyperactivity of hypothalamo-pituitary adrenal (HPA) axis. Type 1 diabetes is associated with higher frequency neuropsychological consequences as mood disorders and structural changes in brain, particularly in hippocampus.
* Purpose: To describe the association between HPA axis activity and anxiety and depression scores in 6-12 year's old diabetes children.
* Abstract: The general objective is to precise the role of HPA axis activity in neuropsychological consequences of type 1 diabetes. The investigators hypothesize that hyperactivity of HPA axis is associated with higher scores of depression and changes in hippocampal volume and mean diffusion.

Eligibility criteria: Inclusion Criteria:

* Diabetic group:

  * diabetes for 1 year
  * 6-12 year's old
  * included in ISIS-DIAB protocol.
* Control group:

  * brother or sister of a diabetic children
  * 6-12 year's old.

Exclusion Criteria:

* Per os or inhaled corticoid in the previous month of inclusion.
* Acute infectious disease in the previous week of inclusion.
* Other chronic disease than diabetes type1.
* Psychiatric disorders or psychiatric treatment.

Primary outcomes:
measure: Mean of nocturnal urinary free cortisol during 5 days.
timeFrame: During 5 days after the inclusion
measure: Depression (CDI) score
timeFrame: At the inclusion
Secondary outcomes:
measure: Mean of awakening salivary cortisol and mean of nocturnal urinary cortisol metabolites during 5 days
timeFrame: During 5 days after the inclusion
measure: Profiles of glucocorticoid sensitive genes expressed in peripheral blood mononuclear cells.
timeFrame: At the inclusion
measure: Anxiety (STAI) score
timeFrame: At the inclusion
measure: Polymorphisms of genes involved in HPA axis activity
timeFrame: At the inclusion
measure: Hippocampal volume and mean diffusion
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Service d'endocrinologie pédiatrique CHG Bayonne Centre Hospitalier de la Côte Basque
state: Aquitaine
city: Bordeaux
country: France
facility: CHU de Bordeaux Hôpital Pellegrin
state: Aquitaine
city: Limoges
country: France
facility: Service d'endocrinologie pédiatrique - Hôpital de la mère et de l'enfant - CHU de LIMOGES
state: Limousin
Study officials:
affiliation: University Hospital, Bordeaux
name: Paul PEREZ, Doctor
role: STUDY_CHAIR
References: