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NCT Number: NCT02377583

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T1DM analyses

Biological

Primary outcomes

  1. Mean of nocturnal urinary free cortisol during 5 days.

    Time frame: During 5 days after the inclusion

  2. Depression (CDI) score

    Time frame: At the inclusion

Secondary outcomes

  1. Mean of awakening salivary cortisol and mean of nocturnal urinary cortisol metabolites during 5 days

    Time frame: During 5 days after the inclusion

  2. Profiles of glucocorticoid sensitive genes expressed in peripheral blood mononuclear cells.

    Time frame: At the inclusion

  3. Anxiety (STAI) score

    Time frame: At the inclusion

  4. Polymorphisms of genes involved in HPA axis activity

    Time frame: At the inclusion

  5. Hippocampal volume and mean diffusion

    Time frame: At the inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: CORTICODIAB

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2015
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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