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Active, Not Recruiting

NCT Number: NCT04007809

Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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 :

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Children under 6 months of age.
  • Treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
  • 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.
  • Obesity defined by a Body Mass Index (BMI) with a z-score >+3 Standard Deviation.
  • Hepatic, renal or adrenal insufficiency.
  • History of spinal cord allograft.
  • History of post-hemolytic-uremic diabetes.
  • Absence of anti-pancreatic islet auto-antibodies.
  • Dysmorphic with suspicion of underlying genetic syndrome.
  • Participation in another study within the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.

Treatment and study plan

glucagon

Other

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

Other names: Glucagen

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%)

    Time frame: up to 18 months after diagnosis

    glycemic variability (%)

  5. Follow-up of laboratory results - glycemia (mg/dL)

    Time frame: up to 18 months after diagnosis

    glycemia (mg/dL)

  6. Follow-up of laboratory results - Insulin (mUI/L)

    Time frame: up to 18 months after diagnosis

    Insulin (mUI/L)

  7. Follow-up of laboratory results - HbA1C (%)

    Time frame: up to 18 months after diagnosis

    HbA1C (%)

  8. Follow-up of laboratory results - C-peptide (mUI/L)

    Time frame: up to 18 months after diagnosis

    C-peptide (mUI/L)

  9. 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)

  10. 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.

  11. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Collaborators

  • BESPEED
  • Fonds National de la Recherche Scientifique

Registry information

Official study title

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

Acronym: DIATAG

Important dates

Study start
2019
Primary completion
2022
Study completion
2027
First posted
Jul 5, 2019
Registry last updated
Jun 28, 2022

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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