Type 1 DiabetesCORTICODIABNCT02377583
Hypothalamo-pituitary Adrenal Axis Activity and Neuropsychological Consequences in Type 1 Diabetes in Childhood
A study testing T1DM analyses in people with Type 1 Diabetes, run by University Hospital, Bordeaux at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- T1DM analyses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 3 sitesFrance
- Study dates
- Aug 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service d'endocrinologie pédiatrique CHG Bayonne Centre Hospitalier de la Côte Basque
Bayonne, Aquitaine, 64000
CHU de Bordeaux Hôpital Pellegrin
Bordeaux, Aquitaine, 33000
Service d'endocrinologie pédiatrique - Hôpital de la mère et de l'enfant - CHU de LIMOGES
Limoges, Limousin, 87000
About this study
Official title: Hypothalamo-pituitary Adrenal Axis Activity: Relation With Neuropsychological Consequences in Type 1 Diabetes in Childhood. The CORTICODIAB Study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- T1DM analyses
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1DM analysesBiological
| Study group | Role | What they receive |
|---|---|---|
| Diabetic children | Experimental | * physical examination
* Glucocorticoid sensitivity index
* DNA sample
* Anxiety and depression questionnaires
* depression questionnaire
* MRI Receives: Biological: T1DM analyses |
| Controls | No intervention | * physical examination * Glucocorticoid sensitivity index * DNA sample * Anxiety and depression questionnaires * depression questionnaire * MRI * Laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of nocturnal urinary free cortisol during 5 days.
Measured: During 5 days after the inclusion
Depression (CDI) score
Measured: At the inclusion
Secondary outcomes (5)
Mean of awakening salivary cortisol and mean of nocturnal urinary cortisol metabolites during 5 days
Measured: During 5 days after the inclusion
Profiles of glucocorticoid sensitive genes expressed in peripheral blood mononuclear cells.
Measured: At the inclusion
Anxiety (STAI) score
Measured: At the inclusion
Polymorphisms of genes involved in HPA axis activity
Measured: At the inclusion
Hippocampal volume and mean diffusion
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startAug 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, Doctor, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377583
- Sponsor's protocol ID
- CHUBX 2011/24
- Other IDs
- 2011-A01435-36
- Acronym
- CORTICODIAB
- Status last verified
- Sep 2015
- First submitted
- 25 Feb 2015
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34970219
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothalamo-pituitary Adrenal Axis Activity: Relation With Neuropsychological Consequences in Type 1 Diabetes in Childhood. The CORTICODIAB Study
- ClinicalTrials.gov ID
- NCT02377583
- Acronym / sponsor ID
- CORTICODIAB / CHUBX 2011/24
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic children | Experimental | Biological: T1DM analyses* 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diabetic group:
- Control group:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1DM analyses | Biological | Diabetic children |
Primary outcome
Mean of nocturnal urinary free cortisol during 5 days.
Time frame: During 5 days after the inclusion
Depression (CDI) score
Time frame: At the inclusion
5 secondary outcomes
Mean of awakening salivary cortisol and mean of nocturnal urinary cortisol metabolites during 5 days
Time frame: During 5 days after the inclusion
Profiles of glucocorticoid sensitive genes expressed in peripheral blood mononuclear cells.
Time frame: At the inclusion
Anxiety (STAI) score
Time frame: At the inclusion
Polymorphisms of genes involved in HPA axis activity
Time frame: At the inclusion
Hippocampal volume and mean diffusion
Time frame: At the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 34970219Brossaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul PEREZ, Doctor study chair
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1DM analyses in people with Type 1 Diabetes, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of nocturnal urinary free cortisol during 5 days. (time frame: During 5 days after the inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.