Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

NCT04007809 | Active Not Recruiting DMC

• 1 other identifier: DIATAG
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type1diabetes

Keywords

type 1 diabetes; children; biomarkers

Outcome Measures

Primary Outcomes (11)

• Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms

  weight in kilograms

  up to 18 months after diagnosis

• Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter

  Height in centimeter

  up to 18 months after diagnosis

• 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

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

  glycemic variability (%)

  up to 18 months after diagnosis

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

  glycemia (mg/dL)

  up to 18 months after diagnosis

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

  Insulin (mUI/L)

  up to 18 months after diagnosis

• Follow-up of laboratory results - HbA1C (%)

  HbA1C (%)

  up to 18 months after diagnosis

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

  C-peptide (mUI/L)

  up to 18 months after diagnosis

• 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

• 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

• 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 Outcomes (1)

• Production of prediction model of β-cell mass evolution

  up to 18 months after diagnosis

Study Arms (1)

New-onset Type 1 diabetes

EXPERIMENTAL

Other: Glucagon

Interventions

Glucagon OTHER

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

Also known as: Glucagen

New-onset Type 1 diabetes

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Fonds National de la Recherche Scientifique: collaborator
• BESPEED: collaborator

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• Polle OG, Delfosse A, Martin M, Louis J, Gies I, den Brinker M, Seret N, Lebrethon MC, Mouraux T, Gatto L, Lysy PA; DIATAG Working Group. Glycemic Variability Patterns Strongly Correlate With Partial Remission Status in Children With Newly Diagnosed Type 1 Diabetes. Diabetes Care. 2022 Oct 1;45(10):2360-2368. doi: 10.2337/dc21-2543.

  PMID: 35994729 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Glucagon-Like Peptides; Gastrointestinal Hormones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: July 5, 2019
• Study Start: June 15, 2019
• Primary Completion: August 15, 2022
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)