Hypothalamo-pituitary Adrenal Axis Activity and Neuropsychological Consequences in Type 1 Diabetes in Childhood
CORTICODIAB
2 other identifiers
interventional
79
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2012
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJune 18, 2026
September 1, 2015
3.1 years
February 25, 2015
June 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Mean of nocturnal urinary free cortisol during 5 days.
During 5 days after the inclusion
Depression (CDI) score
At the inclusion
Secondary Outcomes (5)
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
Study Arms (2)
Diabetic children
EXPERIMENTAL* physical examination * Glucocorticoid sensitivity index * DNA sample * Anxiety and depression questionnaires * depression questionnaire * MRI
Controls
NO INTERVENTION* physical examination * Glucocorticoid sensitivity index * DNA sample * Anxiety and depression questionnaires * depression questionnaire * MRI * Laboratory tests
Interventions
Eligibility Criteria
You may qualify if:
- Diabetic group:
- diabetes for 1 year
- year's old
- included in ISIS-DIAB protocol.
- Control group:
- brother or sister of a diabetic children
- year's old.
You may not qualify if:
- Other chronic disease than diabetes type1.
- Psychiatric disorders or psychiatric treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Service d'endocrinologie pédiatrique CHG Bayonne Centre Hospitalier de la Côte Basque
Bayonne, Aquitaine, 64000, France
CHU de Bordeaux Hôpital Pellegrin
Bordeaux, Aquitaine, 33000, France
Service d'endocrinologie pédiatrique - Hôpital de la mère et de l'enfant - CHU de LIMOGES
Limoges, Limousin, 87000, France
Related Publications (1)
Brossaud J, Corcuff JB, Vautier V, Bergeron A, Valade A, Lienhardt A, Moisan MP, Barat P. Altered Cortisol Metabolism Increases Nocturnal Cortisol Bioavailability in Prepubertal Children With Type 1 Diabetes Mellitus. Front Endocrinol (Lausanne). 2021 Dec 14;12:742669. doi: 10.3389/fendo.2021.742669. eCollection 2021.
PMID: 34970219RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul PEREZ, Doctor
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
August 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
June 18, 2026
Record last verified: 2015-09