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

Primary Purpose

Type1diabetes

Status

Active

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Glucagon

About this trial

This is an interventional diagnostic trial for Type1diabetes focused on measuring type 1 diabetes, children, biomarkers

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
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.

Sites / Locations

Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

New-onset Type 1 diabetes

Arm Description

Outcomes

Primary Outcome Measures

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

weight in kilograms

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

Height in centimeter

Evaluation of T1D subgroups by using follow-up of clinical parameters : Body mass index (kg/m²)

Body mass index (kg/m²)

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

glycemic variability (%)

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

glycemia (mg/dL)

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

Insulin (mUI/L)

Follow-up of laboratory results - HbA1C (%)

HbA1C (%)

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

C-peptide (mUI/L)

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)

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.

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.

Secondary Outcome Measures

Production of prediction model of β-cell mass evolution

Composite score using clinical parameters and laboratory results

Full Information

NCT ID

NCT04007809

First Posted

June 3, 2019

Last Updated

June 27, 2022

Sponsor

Université Catholique de Louvain

Collaborators

Fonds National de la Recherche Scientifique, BESPEED

1. Study Identification

Unique Protocol Identification Number

NCT04007809

Brief Title

Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

Acronym

DIATAG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 15, 2019 (Actual)

Primary Completion Date

August 15, 2022 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Université Catholique de Louvain

Collaborators

Fonds National de la Recherche Scientifique, BESPEED

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1diabetes

Keywords

type 1 diabetes, children, biomarkers

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

New-onset Type 1 diabetes

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Glucagon

Other Intervention Name(s)

Glucagen

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

weight in kilograms

Time Frame

up to 18 months after diagnosis

Title

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

Description

Height in centimeter

Time Frame

up to 18 months after diagnosis

Title

Evaluation of T1D subgroups by using follow-up of clinical parameters : Body mass index (kg/m²)

Description

Body mass index (kg/m²)

Time Frame

up to 18 months after diagnosis

Title

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

Description

glycemic variability (%)

Time Frame

up to 18 months after diagnosis

Title

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

Description

glycemia (mg/dL)

Time Frame

up to 18 months after diagnosis

Title

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

Description

Insulin (mUI/L)

Time Frame

up to 18 months after diagnosis

Title

Follow-up of laboratory results - HbA1C (%)

Description

HbA1C (%)

Time Frame

up to 18 months after diagnosis

Title

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

Description

C-peptide (mUI/L)

Time Frame

up to 18 months after diagnosis

Title

Evaluation and follow-up of diet, physical activity, quality of life using validated questionnaires.

Description

Composite of Physical Activity Questionnaire (PAQ), DisabKids, Health Behaviour in School-aged Children (HBSC)

Time Frame

up to 18 months after diagnosis

Title

Evaluation and follow-up of physical activity

Description

Time Frame

up to 18 months after diagnosis

Title

Evaluation and follow-up of quality of life: DisabKids Questionnaires

Description

Time Frame

up to 18 months after diagnosis

Secondary Outcome Measure Information:

Title

Production of prediction model of β-cell mass evolution

Description

Composite score using clinical parameters and laboratory results

Time Frame

up to 18 months after diagnosis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35994729

Citation

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.

Results Reference

derived

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Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

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