Type 1 Diabetes in Children Clinical Trial
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
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.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science