Type1diabetes
Conditions
Keywords
type 1 diabetes, children, biomarkers
Brief summary
The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.
Detailed description
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 : 1. Different subgroups of T1D patients might exist, underlying different physiopathology of T1D : * The investigators will first investigate the presence of biomarkers in different fluids (e.g. urine, blood, feces,...). * The investigators will correlate results with clinical parameters of glycemic control. Dynamic tests (HOMA and stimulated C peptide) will be realized at 2 defined time points of the follow-up. 2. 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.
Interventions
OTHERGlucagon
Every patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg).
Sponsors
Fonds National de la Recherche Scientifique
BESPEED
Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Type 1 diabetes de novo according to American Diabetes Association criteria: 1. Polyuria, polydipsia, weight loss ± ketoacidosis 2. Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at the 120th minute of an Oral Glucose Tolerance Test (OGTT) AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg/dL. 3. Presence in the serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8) 2. Age between 6 months and 18 years. 3. Male or female. 4. Positive for one or more autoantibodies typically associated with Type 1 Diabetes (TD1). 5. Free written and oral consent.
Exclusion criteria
1. Children under 6 months of age. 2. Treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins). 3. Presence of celiac disease (diagnosis based on pathological duodenal biopsy), recently diagnosed (within 1 month), at the time of inclusion. 4. Autoimmune/auto-inflammatory disease (other than type 1 diabetes) or active malignant disease present at inclusion. 5. Obesity defined by a Body Mass Index (BMI) with a z-score \>+3 Standard Deviation. 6. Hepatic, renal or adrenal insufficiency. 7. History of spinal cord allograft. 8. History of post-hemolytic-uremic diabetes. 9. Absence of anti-pancreatic islet auto-antibodies. 10. Dysmorphic with suspicion of underlying genetic syndrome. 11. Participation in another study within the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation and follow-up of quality of life: DisabKids Questionnaires | up to 18 months after diagnosis | 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. |
| Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms | up to 18 months after diagnosis | weight in kilograms |
| Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter | up to 18 months after diagnosis | Height in centimeter |
| Evaluation of T1D subgroups by using follow-up of clinical parameters : Body mass index (kg/m²) | up to 18 months after diagnosis | Body mass index (kg/m²) |
| Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%) | up to 18 months after diagnosis | glycemic variability (%) |
| Follow-up of laboratory results - glycemia (mg/dL) | up to 18 months after diagnosis | glycemia (mg/dL) |
| Follow-up of laboratory results - Insulin (mUI/L) | up to 18 months after diagnosis | Insulin (mUI/L) |
| Follow-up of laboratory results - HbA1C (%) | up to 18 months after diagnosis | HbA1C (%) |
| Follow-up of laboratory results - C-peptide (mUI/L) | up to 18 months after diagnosis | C-peptide (mUI/L) |
| Evaluation and follow-up of diet, physical activity, quality of life using validated questionnaires. | up to 18 months after diagnosis | Composite of Physical Activity Questionnaire (PAQ), DisabKids, Health Behaviour in School-aged Children (HBSC) |
| Evaluation and follow-up of physical activity | up to 18 months after diagnosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Production of prediction model of β-cell mass evolution | up to 18 months after diagnosis | Composite score using clinical parameters and laboratory results |
Countries
Belgium
Outcome results
None listed