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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02377583

Acronym

CORTICODIAB

Enrollment

Registered

2015-03-03

Start date

2012-08-01

Completion date

2015-09-01

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

BIOLOGICALT1DM analyses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
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

Countries

France

Contacts

STUDY_CHAIRPaul PEREZ, Doctor

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026