Low Grade Inflammation in Type 1 Diabetes Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study propose to measure the inflammation level in type 1 diabetes children with the cytokine analysis compared to non diabetic children of the same sibling and to healthy children.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The increase of type 1 diabetes incidence, particularly in young children leads to conduce new diagnostic and therapeutic strategies, notably for associated chronic morbidity.Measurement of chronic inflammation, with modification of the balance between pro-inflammatory cytokines and anti-inflammatory cytokines, could lead to detect patients with high risk to diabetes chronic morbidity.

After parental consent, blood sampling will be carried out by micromethod for cytokine (500 µl) and CRPhs dosages and glycemia (100 µl) and glycated hemoglobin (1 µl). Urine will be collected (50 ml) in the morning for further researches.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

diabetes group

No interventions assigned to this group

control group

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Type 1 diabetes children group :

* Children aged 2 to 17 years
* Type 1 diabetes children

Controlled group :

* Children aged 2 to 17 years
* Brother or sister of type 1 diabetes children

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pascal BARAT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children Hospital, Endocrinology Unit

Bordeaux, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHUBX 2009/28

Identifier Type: -

Identifier Source: org_study_id