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| Name | Class |
|---|---|
| Fonds National de la Recherche Scientifique | OTHER |
| BESPEED | UNKNOWN |
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The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.
Type 1 diabetes (T1D) is a common chronic disease in childhood. Clinical presentation at onset of T1D can vary among patients from long-standing diabetes triad symptoms (polyuria, polydipsia and weight loss) to coma and ketoacidosis. The initial clinical presentation of T1D was shown to have long-term influence on glycemic control of the patient. The investigators initiated a collaborative consortium including six pediatric clinics in Belgium to better characterize new-onset T1D patients.
Hypothesis :
Different subgroups of T1D patients might exist, underlying different physiopathology of T1D :
Glucose variability can be influenced by external factors (e.g. diet, physical activity, Quality of Life (QoL),...) The investigators will evaluate those external factors using approved questionnaires. They will presented to the patient and its parents at 2 defined time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New-onset Type 1 diabetes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon | Other | Every patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms | weight in kilograms | up to 18 months after diagnosis |
| Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter | Height in centimeter | up to 18 months after diagnosis |
| Evaluation of T1D subgroups by using follow-up of clinical parameters : Body mass index (kg/m²) | Body mass index (kg/m²) | up to 18 months after diagnosis |
| Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%) | glycemic variability (%) | up to 18 months after diagnosis |
| Follow-up of laboratory results - glycemia (mg/dL) | glycemia (mg/dL) | up to 18 months after diagnosis |
| Follow-up of laboratory results - Insulin (mUI/L) | Insulin (mUI/L) | up to 18 months after diagnosis |
| Follow-up of laboratory results - HbA1C (%) | HbA1C (%) | up to 18 months after diagnosis |
| Follow-up of laboratory results - C-peptide (mUI/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Production of prediction model of β-cell mass evolution | Composite score using clinical parameters and laboratory results | up to 18 months after diagnosis |
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Inclusion Criteria:
Type 1 diabetes de novo according to American Diabetes Association criteria:
Age between 6 months and 18 years.
Male or female.
Positive for one or more autoantibodies typically associated with Type 1 Diabetes (TD1).
Free written and oral consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35994729 | Derived | Polle OG, Delfosse A, Martin M, Louis J, Gies I, den Brinker M, Seret N, Lebrethon MC, Mouraux T, Gatto L, Lysy PA; DIATAG Working Group. Glycemic Variability Patterns Strongly Correlate With Partial Remission Status in Children With Newly Diagnosed Type 1 Diabetes. Diabetes Care. 2022 Oct 1;45(10):2360-2368. doi: 10.2337/dc21-2543. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
C-peptide (mUI/L)
| up to 18 months after diagnosis |
| Evaluation and follow-up of diet, physical activity, quality of life using validated questionnaires. | Composite of Physical Activity Questionnaire (PAQ), DisabKids, Health Behaviour in School-aged Children (HBSC) | up to 18 months after diagnosis |
| Evaluation and follow-up of physical activity | Physical Activity Questionnaire (PAQ). This questionnaire consists of 8 items. Once you have a value from 1 to 5 for each of the 8 items (items 1 to 8) used in the Physical Activity composite score, you simply take the mean of these 8 items, which results in the final PAQ activity summary score. A score of 1 indicates low physical activity, wheareas a score of 5 indicates high physical activity. | up to 18 months after diagnosis |
| Evaluation and follow-up of quality of life: DisabKids Questionnaires | DisabKids Questionnaires. The paper version of DISABKIDS consisted of the generic health related quality of life questionnaire for 8- to 18-year-olds (37 items) and the DISABKIDS Diabetes module (10 items). The questionnaire is designed to measure health related quality of life of children with a chronic medical condition. Questions are answered on a Likert type scale of 1-5 points. Lower scores correspond to better quality of life. | up to 18 months after diagnosis |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004763 | Glucagon-Like Peptides |
| D005768 | Gastrointestinal Hormones |