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Active Not RecruitingNCT04007809

Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

Phenotypic and Genotypic Characterization of a Cohort of Pediatric Patients With New-onset Type 1 Diabetes

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Université Catholique de Louvain · Academic / Other
Sex
All
Age
6 Months – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERGlucagonEvery patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg).

Timeline

Start date
2019-06-15
Primary completion
2022-08-15
Completion
2027-06-30
First posted
2019-07-05
Last updated
2022-06-28

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04007809. Inclusion in this directory is not an endorsement.