Type 1 DiabetesCoccinelleNCT01099956
Low Grade Inflammation in Type 1 Diabetes Children
An observational study of Type 1 Diabetes and Inflammation, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Inflammation
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jul 2010
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 60 children in type 1 diabetes group and 30 children in control group
Who may be able to join
- 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
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Type 1 Diabetes, Inflammation
- Keywords
- type 1 diabetes, children, low grade inflammation, cytokine, CRP
- Medical subject headings
- Diabetes Mellitus, Type 1, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diabetes group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of Interleukine 6 in group DTI versus control group
Measured: Once at inclusion
Secondary outcomes (1)
Increase of others cytokines (IL1-beta, l'IL-4, l'IL-10 and TNF alpha) and increase of High sensitivity CRP in group DTI versus control group
Measured: Once at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal BARAT, MD, Principal investigator, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099956
- Sponsor's protocol ID
- CHUBX 2009/28
- Acronym
- Coccinelle
- Status last verified
- Oct 2011
- First submitted
- 22 Mar 2010
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Grade Inflammation in Type 1 Diabetes Children
- ClinicalTrials.gov ID
- NCT01099956
- Acronym / sponsor ID
- Coccinelle / CHUBX 2009/28
- Conditions
- Type 1 Diabetes, Inflammation
- Keywords
- type 1 diabetes, children, low grade inflammation, cytokine, CRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 8 Apr 2010 (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 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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetes group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 60 children in type 1 diabetes group and 30 children in control group
Key inclusion criteria (6 listed)
- Children aged 2 to 17 years
- Type 1 diabetes children
- Children aged 2 to 17 years
- Brother or sister of type 1 diabetes children
Key exclusion criteria (3 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase of Interleukine 6 in group DTI versus control group
Time frame: Once at inclusion
1 secondary outcome
Increase of others cytokines (IL1-beta, l'IL-4, l'IL-10 and TNF alpha) and increase of High sensitivity CRP in group DTI versus control group
Time frame: Once at 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 25 Oct 2011.
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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.
Pascal BARAT, MD principal investigator
University Hospital, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Inflammation, run by University Hospital, Bordeaux at 1 site 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 6 inclusion and 3 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 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Increase of Interleukine 6 in group DTI versus control group (time frame: Once at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2011.