Type1diabetes Clinical Trial
— DIATAGOfficial title:
Phenotypic and Genotypic Characterization of a Cohort of Pediatric Patients With New-onset Type 1 Diabetes
Verified date | June 2022 |
Source | Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.
Status | Active, not recruiting |
Enrollment | 98 |
Est. completion date | June 30, 2027 |
Est. primary completion date | August 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires Saint-Luc | Brussels |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain | BESPEED, Fonds National de la Recherche Scientifique |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms | weight in kilograms | up to 18 months after diagnosis | |
Primary | Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter | Height in centimeter | up to 18 months after diagnosis | |
Primary | 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 | |
Primary | Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%) | glycemic variability (%) | up to 18 months after diagnosis | |
Primary | Follow-up of laboratory results - glycemia (mg/dL) | glycemia (mg/dL) | up to 18 months after diagnosis | |
Primary | Follow-up of laboratory results - Insulin (mUI/L) | Insulin (mUI/L) | up to 18 months after diagnosis | |
Primary | Follow-up of laboratory results - HbA1C (%) | HbA1C (%) | up to 18 months after diagnosis | |
Primary | Follow-up of laboratory results - C-peptide (mUI/L) | C-peptide (mUI/L) | up to 18 months after diagnosis | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | Production of prediction model of ß-cell mass evolution | Composite score using clinical parameters and laboratory results | up to 18 months after diagnosis |
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