Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
NCT Number: NCT04007809
The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.
This study is active but is not currently recruiting participants.
6 month–18 year
All sexes
Interventional
Not applicable
Brussels, 1200, Belgium
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Every patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg).
Other names: Glucagen
Time frame: up to 18 months after diagnosis
weight in kilograms
Time frame: up to 18 months after diagnosis
Height in centimeter
Time frame: up to 18 months after diagnosis
Body mass index (kg/m²)
Time frame: up to 18 months after diagnosis
glycemic variability (%)
Time frame: up to 18 months after diagnosis
glycemia (mg/dL)
Time frame: up to 18 months after diagnosis
Insulin (mUI/L)
Time frame: up to 18 months after diagnosis
HbA1C (%)
Time frame: up to 18 months after diagnosis
C-peptide (mUI/L)
Time frame: up to 18 months after diagnosis
Composite of Physical Activity Questionnaire (PAQ), DisabKids, Health Behaviour in School-aged Children (HBSC)
Time frame: 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.
Time frame: 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.
Time frame: up to 18 months after diagnosis
Composite score using clinical parameters and laboratory results
Université Catholique de Louvain
Other
Phenotypic and Genotypic Characterization of a Cohort of Pediatric Patients With New-onset Type 1 Diabetes
Acronym: DIATAG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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