NCT04007809Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 28 Jun 2022
Brief summary (registry, in English)
The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 98 (actual)
- First submitted
- 3 Jun 2019
- Start date
- 15 Jun 2019
- Primary completion date
- 15 Aug 2022
- Lead sponsor
- Université Catholique de Louvain
- Diseases
- Type 1 diabetes
- NCT number
- NCT04007809
What you commit to
- Study type: Interventional
- Participants enrolled: 98
- From 15 Jun 2019 to the primary completion date, 15 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
- Absence of anti-pancreatic islet auto-antibodies.
- Participation in another study within the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
Other illness
- Presence of celiac disease (diagnosis based on pathological duodenal biopsy), recently diagnosed (within 1 month), at the time of inclusion.
- Autoimmune/auto-inflammatory disease (other than type 1 diabetes) or active malignant disease present at inclusion.
- Hepatic, renal or adrenal insufficiency.
- History of spinal cord allograft.
- History of post-hemolytic-uremic diabetes.
- Dysmorphic with suspicion of underlying genetic syndrome.
Age
- Children under 6 months of age.
Other
- Obesity defined by a Body Mass Index (BMI) with a z-score \>+3 Standard Deviation.
Who the study is looking for
- Type 1 diabetes de novo according to American Diabetes Association criteria:
- Polyuria, polydipsia, weight loss ± ketoacidosis
- 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.
- Presence in the serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
- Age between 6 months and 18 years.
- Male or female.
- Positive for one or more autoantibodies typically associated with Type 1 Diabetes (TD1).
- Free written and oral consent.
Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.