Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

Type1diabetes Clinical Trial

— DIATAG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04007809
• Other study ID #: DIATAG
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2022
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (3)

Lead Sponsor	Collaborator
Université Catholique de Louvain	BESPEED, Fonds National de la Recherche Scientifique

Country where clinical trial is conducted

Belgium, 

Outcome

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