NCT02377583

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 3, 2015

Status Verified

February 1, 2015

Enrollment Period

3.5 years

First QC Date

February 25, 2015

Last Update Submit

February 25, 2015

Conditions

Type 1 Diabetes

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

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

Controls

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

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

* Age: The investigators will limit the study to children at least 6 years, to ensure the successful completion of saliva samples and MRI without anesthesia. The investigators limit themselves to prepubescent children do not have to take into account the influence of sex steroids on the AC activity. * Gender: Although it is expected differences in hippocampal volume and CA activity between boys and girls, the relationship between these two variables is not necessarily different for boys and girls. Thus, the inclusion of both sexes in the analysis is not necessarily problematic, and will be more informative. So it has been finally decided to include boys and girls in the sample of subjects undergoing MRI. * Population control: The constitution of a control group from the siblings will enable to study the specific effect of diabetes on anxiety and depression, regardless of the children's education mode in the same family environment.

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

RECRUITING

CHU de Bordeaux Hôpital Pellegrin

Bordeaux, Aquitaine, 33000, France

RECRUITING

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

Limoges, Limousin, 87000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

20ml blood sample in order to evaluate: * NR3C1 (GR) gene * NR3C2 (MR) gene * FKBP5 gene * CRH gene * CRHR1 gene * CBG gene

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paul PEREZ, Doctor

    University Hospital, Bordeaux

    STUDY CHAIR

Central Study Contacts

Pascal BARAT, Professor

CONTACT

05 56 79 87 25pascal.barat@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
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

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 3, 2015

Record last verified: 2015-02

Locations

FR(3)