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Phenotypic and Genotypic Characterization of New-onset Type I Diabetes (DIATAG)

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ClinicalTrials.gov Identifier: NCT04007809
Recruitment Status : Recruiting
First Posted : July 3, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
FNRS
BESPEED
Information provided by (Responsible Party):
Université Catholique de Louvain

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

Condition or disease Intervention/treatment Phase
Type1diabetes Other: Glucagon Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: New-onset Type 1 diabetes Other: Glucagon
Every patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg).
Other Name: Glucagen




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Philippe A Lysy, MD, PhD 0032 2 764 13 70 philippe.lysy@uclouvain.be
Contact: Olivier Polle, MD 0032 2 764 13 70 olivier.polle@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Philippe Lysy       philippe.lysy@uclouvain.be   
Contact: Olivier Polle       olivier.polle@uclouvain.be   
Sponsors and Collaborators
Université Catholique de Louvain
FNRS
BESPEED

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Responsible Party: Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04007809     History of Changes
Other Study ID Numbers: DIATAG
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Université Catholique de Louvain:
type 1 diabetes
children
biomarkers

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins