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

Type 1 Diabetes Clinical Trial

— CORTICODIAB  

Official title:

Hypothalamo-pituitary Adrenal Axis Activity: Relation With Neuropsychological Consequences in Type 1 Diabetes in Childhood. The CORTICODIAB Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02377583
• Other study ID #: CHUBX 2011/24
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2015
• Last updated: February 25, 2015
• Start date: August 2012
• Est. completion date: February 2016

Study information

• Verified date: February 2015
• Source: University Hospital, Bordeaux
• Contact: Pascal BARAT, Professor
• Phone: 05 56 79 87 25
• Email: pascal.barat[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
France	Service d'endocrinologie pédiatrique CHG Bayonne Centre Hospitalier de la Côte Basque	Bayonne	Aquitaine
France	CHU de Bordeaux Hôpital Pellegrin	Bordeaux	Aquitaine
France	Service d'endocrinologie pédiatrique - Hôpital de la mère et de l'enfant - CHU de LIMOGES	Limoges	Limousin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of nocturnal urinary free cortisol during 5 days.		During 5 days after the inclusion	No
Primary	Depression (CDI) score		At the inclusion	No
Secondary	Mean of awakening salivary cortisol and mean of nocturnal urinary cortisol metabolites during 5 days		During 5 days after the inclusion	No
Secondary	Profiles of glucocorticoid sensitive genes expressed in peripheral blood mononuclear cells.		At the inclusion	No
Secondary	Anxiety (STAI) score		At the inclusion	No
Secondary	Polymorphisms of genes involved in HPA axis activity		At the inclusion	No
Secondary	Hippocampal volume and mean diffusion		At the inclusion	No