Type 1 Diabetes in ChildrenAGEDIANCT02793427
Patient With Any Pathology (According to the Appreciation of the Investigator) Which Could Disturb the Participation in the Study
A study testing blood sample collection in people with Type 1 Diabetes in Children, run by CHU de Reims at 1 site in France.
Trial summary
The objective of the study is to quantify the products of non-enzymatic glycation of proteins (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients without clinical complications in order to define the contribution of this markers in the long-term monitoring of glycemic control in… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes in Children
- What is being tested?
- blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jun 2019
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patient with a monogenic diabetes or MODY diabetes who does not require permanent insulin therapy.
- Patient with any pathology (according to the appreciation of the investigator) which could disturb the participation in the study
- Control subjects
- Control subject requiring long-term or frequently corticosteroid treatment or any treatment that may disturb glucose metabolism
- Control subject with chronic disease or a history of severe disease (malignant disease, kidney or liver disease, ...)
- Control subject with significant ongoing or recovering acute disease
- Control subject with obesity (BMI greater than the 97th percentile compared to the reference curves of the evolution of BMI according to age).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Advanced Glycation End Products of Proteins as a Long-term Retrospective Markers of Glycemic Control in a Population of Non-complicated Type 1 Diabetic Children.
The objective of the study is to quantify the products of non-enzymatic glycation of proteins (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients without clinical complications in order to define the contribution of this markers in the long-term monitoring of glycemic control in these patients. The results will define the criteria for using these new markers in daily clinical practice for the monitoring of these patients
Read the detailed description
Primary objective : Determine whether AGEs could serve as long-term retrospective indicators of glycemic control of type 1 diabetic patients and determine how to use these markers in a clinical practice for therapeutic purpose and patient monitoring.
For this purpose, it is necessary to determine baseline and pathophysiological ranges of concentrations for serum AGEs and to find a link between AGEs and glycemic control Secondary objectives: (1) Evaluation of the early predictive potential of AGEs for the onset of diabetes complications. (2) Measurement of fructosamine-3-kinase erythrocyte activity and evaluation of its effect on glycemic control in diabetic patients and on the accumulation of AGEs. (3) Ancillary study: development of new methods of evaluation of glycation of serum proteins based on the use of innovative technologies such as vibrational spectroscopy (Raman and infrared).
Protocol design: Cross-sectional and single-center study using a cohort of diabetic children who will be followed over a period of 5 years. Population / patients: 118 children with type 1 diabetes children without clinical complications and 33 non-diabetic children. The group of patients will be stratified on the duration of diabetes: enrolled at the time of the discovery of diabetes or during follow-up of a previously known diabetes. Control subjects will be recruited among siblings of diabetic patients followed at the University Hospital of Reims and among non-diabetic patients treated at the Hospital of Reims for a disease that does not interfere with the protocol, with a matching on age ± 2 years.
Plan of investigation: First phase: after collecting information and informed consent of the child and the holders of parental authority, inclusion of patients achieving blood samples for all children (control and diabetic). For diabetic patients, this blood collection is included in their follow-up. Thus, no additional sample is necessary for the protocol. Second phase: monitoring of diabetic children with blood and urine samples and measurement of skin fluorescence at 5 years after inclusion. No follow-up is planned for control subjects.
Conduct of the study: Inclusion of patients and blood collection. Determination of AGEs (pentosidine, carboxymethyllysine and MG-H1) by high performance liquid chromatography coupled with tandem mass spectrometry by the Laboratory of Biology and Pediatric Research.
Statistical Analyses: Find a link between type 1 diabetes and AGE concentrations and a link between diabetes duration and concentrations of AGE by a Student test.ROC Curves to propose reference values for concentrations of AGE. Find a link between AGE concentrations and HbA1c values by Spearman correlation test and a link between AGE concentrations and HbA1c values (HbA1c <7.5% / 7.5% <HbA1c <8.5% / HbA1c> 8.5%) by a simple linear regression or a Kruskal Wallis test. Find a link between AGE concentrations and magnitudes of change in HbA1c by Spearman correlation test or Pearson.
- Conditions
- Type 1 Diabetes in Children
- Being tested
- blood sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collectionBiological
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Experimental | Not described Receives: Biological: blood sample collection |
| control | Experimental | Not described Receives: Biological: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum AGEs
Measured: 5 years after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startFeb 2011
- Primary completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes in ChildrenStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793427
- Sponsor's protocol ID
- PA10007
- Acronym
- AGEDIA
- Status last verified
- Jun 2016
- First submitted
- 27 May 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Glycation End Products of Proteins as a Long-term Retrospective Markers of Glycemic Control in a Population of Non-complicated Type 1 Diabetic Children.
- ClinicalTrials.gov ID
- NCT02793427
- Acronym / sponsor ID
- AGEDIA / PA10007
- Conditions
- Type 1 Diabetes in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2019 (estimated)
- First posted
- 8 Jun 2016 (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 objective of the study is to quantify the products of non-enzymatic glycation of proteins (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients without clinical complications in order to define the contribution of this markers in the long-term monitoring of glycemic control in these patients. The results will define the criteria for using these new markers in daily clinical practice for the monitoring of these patients
Detailed description
Primary objective : Determine whether AGEs could serve as long-term retrospective indicators of glycemic control of type 1 diabetic patients and determine how to use these markers in a clinical practice for therapeutic purpose and patient monitoring.
For this purpose, it is necessary to determine baseline and pathophysiological ranges of concentrations for serum AGEs and to find a link between AGEs and glycemic control Secondary objectives: (1) Evaluation of the early predictive potential of AGEs for the onset of diabetes complications. (2) Measurement of fructosamine-3-kinase erythrocyte activity and evaluation of its effect on glycemic control in diabetic patients and on the accumulation of AGEs. (3) Ancillary study: development of new methods of evaluation of glycation of serum proteins based on the use of innovative technologies such as vibrational spectroscopy (Raman and infrared).
Protocol design: Cross-sectional and single-center study using a cohort of diabetic children who will be followed over a period of 5 years. Population / patients: 118 children with type 1 diabetes children without clinical complications and 33 non-diabetic children. The group of patients will be stratified on the duration of diabetes: enrolled at the time of the discovery of diabetes or during follow-up of a previously known diabetes. Control subjects will be recruited among siblings of diabetic patients followed at the University Hospital of Reims and among non-diabetic patients treated at the Hospital of Reims for a disease that does not interfere with the protocol, with a matching on age ± 2 years.
Plan of investigation: First phase: after collecting information and informed consent of the child and the holders of parental authority, inclusion of patients achieving blood samples for all children (control and diabetic). For diabetic patients, this blood collection is included in their follow-up. Thus, no additional sample is necessary for the protocol. Second phase: monitoring of diabetic children with blood and urine samples and measurement of skin fluorescence at 5 years after inclusion. No follow-up is planned for control subjects.
Conduct of the study: Inclusion of patients and blood collection. Determination of AGEs (pentosidine, carboxymethyllysine and MG-H1) by high performance liquid chromatography coupled with tandem mass spectrometry by the Laboratory of Biology and Pediatric Research.
Statistical Analyses: Find a link between type 1 diabetes and AGE concentrations and a link between diabetes duration and concentrations of AGE by a Student test.ROC Curves to propose reference values for concentrations of AGE. Find a link between AGE concentrations and HbA1c values by Spearman correlation test and a link between AGE concentrations and HbA1c values (HbA1c <7.5% / 7.5% <HbA1c <8.5% / HbA1c> 8.5%) by a simple linear regression or a Kruskal Wallis test. Find a link between AGE concentrations and magnitudes of change in HbA1c by Spearman correlation test or Pearson.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | Experimental | Biological: blood sample collection |
| control | Experimental | Biological: blood sample collection |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patient with a monogenic diabetes or MODY diabetes who does not require permanent insulin therapy.
- Patient with any pathology (according to the appreciation of the investigator) which could disturb the participation in the study
- Control subjects
- Control subject requiring long-term or frequently corticosteroid treatment or any treatment that may disturb glucose metabolism
- Control subject with chronic disease or a history of severe disease (malignant disease, kidney or liver disease, ...)
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 |
|---|---|---|
| blood sample collection | Biological | Type 1 diabetes, control |
Primary outcome
Serum AGEs
Time frame: 5 years after the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample collection in people with Type 1 Diabetes in Children, run by CHU de Reims 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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Jun 2016. 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?
Results are not available in the source record.
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?
Serum AGEs (time frame: 5 years after the 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 9 Jun 2016.