Phenotypic and Genotypic Characterization of New-onset Type I Diabetes (DIATAG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04007809|
Recruitment Status : Recruiting
First Posted : July 3, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type1diabetes||Other: Glucagon||Not Applicable|
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.
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phenotypic and Genotypic Characterization of a Cohort of Pediatric Patients With New-onset Type 1 Diabetes|
|Actual Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||June 15, 2022|
|Estimated Study Completion Date :||June 30, 2022|
|Experimental: New-onset Type 1 diabetes||
Every patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg).
Other Name: Glucagen
- Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms [ Time Frame: up to 18 months after diagnosis ]weight in kilograms
- Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter [ Time Frame: 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) [ Time Frame: up to 18 months after diagnosis ]Body mass index (kg/m²)
- Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%) [ Time Frame: up to 18 months after diagnosis ]glycemic variability (%)
- Follow-up of laboratory results - glycemia (mg/dL) [ Time Frame: up to 18 months after diagnosis ]glycemia (mg/dL)
- Follow-up of laboratory results - Insulin (mUI/L) [ Time Frame: up to 18 months after diagnosis ]Insulin (mUI/L)
- Follow-up of laboratory results - HbA1C (%) [ Time Frame: up to 18 months after diagnosis ]HbA1C (%)
- Follow-up of laboratory results - C-peptide (mUI/L) [ Time Frame: up to 18 months after diagnosis ]C-peptide (mUI/L)
- Evaluation and follow-up of diet, physical activity, quality of life using validated questionnaires. [ Time Frame: 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 [ 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.
- Evaluation and follow-up of quality of life: DisabKids Questionnaires [ 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.
- Production of prediction model of β-cell mass evolution [ Time Frame: up to 18 months after diagnosis ]Composite score using clinical parameters and laboratory results
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007809
|Contact: Philippe A Lysy, MD, PhD||0032 2 764 13 firstname.lastname@example.org|
|Contact: Olivier Polle, MD||0032 2 764 13 email@example.com|
|Cliniques universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, 1200|
|Contact: Philippe Lysy firstname.lastname@example.org|
|Contact: Olivier Polle email@example.com|