Patient With Any Pathology (According to the Appreciation of the Investigator) Which Could Disturb the Participation in the Study
AGEDIA
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.
1 other identifier
interventional
160
1 country
1
Brief 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 these patients. The results will define the criteria for using these new markers in daily clinical practice for the monitoring of these patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedJune 9, 2016
June 1, 2016
8.3 years
May 27, 2016
June 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Serum AGEs
5 years after the inclusion
Study Arms (2)
Type 1 diabetes
EXPERIMENTALcontrol
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient aged 1-18 years recruited according to the duration of diabetes
- Patient with type 1 diabetes
- Patient without clinical diabetes complications
- Patient and his parents have agreed and signed the informed consent for participation
- Control subjects
- Control subjects recruited among the siblings of all diabetes patients followed at the University Hospital of Reims.
- Non-diabetic patient followed at Reims University Hospital for a disease which, according to the appreciation of the investigator, may not interfere with the current protocol and the expected results.
- Obtaining informed consent from the Patient and from the holder of parental authority.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu Reims
Reims, France, 51092, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2016
First Posted
June 8, 2016
Study Start
February 1, 2011
Primary Completion
June 1, 2019
Last Updated
June 9, 2016
Record last verified: 2016-06