Hypothalamo-pituitary Adrenal Axis Activity and Neuropsychological Consequences in Type 1 Diabetes in Childhood

• Conditions: Type 1 Diabetes

• Registration Number: NCT02377583
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2012-08
• Status Verified: 2015-02
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean of nocturnal urinary free cortisol during 5 days.	During 5 days after the inclusion
Depression (CDI) score	At the inclusion

Secondary Outcome Measures

Name	Time	Method
Anxiety (STAI) score	At the inclusion
Polymorphisms of genes involved in HPA axis activity	At the inclusion
Hippocampal volume and mean diffusion	At the inclusion
Mean of awakening salivary cortisol and mean of nocturnal urinary cortisol metabolites during 5 days	During 5 days after the inclusion
Profiles of glucocorticoid sensitive genes expressed in peripheral blood mononuclear cells.	At the inclusion

Trial Locations

Locations (3)

Service d'endocrinologie pédiatrique CHG Bayonne Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, Aquitaine, France

Service d'endocrinologie pédiatrique - Hôpital de la mère et de l'enfant - CHU de LIMOGES; 🇫🇷 Limoges, Limousin, France

CHU de Bordeaux Hôpital Pellegrin; 🇫🇷 Bordeaux, Aquitaine, France