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

NCT ID: NCT02377583

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-02-29

Brief Summary

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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

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* 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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic children

* physical examination
* Glucocorticoid sensitivity index
* DNA sample
* Anxiety and depression questionnaires
* depression questionnaire
* MRI

No interventions assigned to this group

Controls

* physical examination
* Glucocorticoid sensitivity index
* DNA sample
* Anxiety and depression questionnaires
* depression questionnaire
* MRI
* Laboratory tests

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul PEREZ, Doctor

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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Service d'endocrinologie pédiatrique CHG Bayonne Centre Hospitalier de la Côte Basque

Bayonne, Aquitaine, France

Site Status RECRUITING

CHU de Bordeaux Hôpital Pellegrin

Bordeaux, Aquitaine, France

Site Status RECRUITING

Service d'endocrinologie pédiatrique - Hôpital de la mère et de l'enfant - CHU de LIMOGES

Limoges, Limousin, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pascal BARAT, Professor

Role: CONTACT

05 56 79 87 25

Facility Contacts

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Aurélie VALADE, Doctor

Role: primary

05 59 44 38 74

Pascal BARAT, Professor

Role: primary

05 56 79 87 25

Virginie SAINTIGNAN

Role: backup

05 57 82 02 04

Anne LIENHARDT, Professor

Role: primary

05 55 05 63 58

Cécile ETOUBLEAU-JACOT, Doctor

Role: backup

Other Identifiers

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CHUBX 2011/24

Identifier Type: -

Identifier Source: org_study_id

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