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出境医 / 临床实验 / Phenotypic and Genotypic Characterization of New-onset Type I Diabetes (DIATAG)
Phenotypic and Genotypic Characterization of New-onset Type I Diabetes (DIATAG)
Study Description
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 :
-
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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
- 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
- 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)
- Evaluation of T1D subgroups by using follow-up of clinical parameters : glycemic variability (%) [ Time Frame: up to 18 months after diagnosis ]glycemic variability (%)
- Follow-up of laboratory results - glycemia (mg/dL) [ Time Frame: up to 18 months after diagnosis ]glycemia (mg/dL)
- Follow-up of laboratory results - Insulin (mUI/L) [ Time Frame: up to 18 months after diagnosis ]Insulin (mUI/L)
- Follow-up of laboratory results - HbA1C (%) [ Time Frame: up to 18 months after diagnosis ]HbA1C (%)
- Follow-up of laboratory results - C-peptide (mUI/L) [ Time Frame: up to 18 months after diagnosis ]C-peptide (mUI/L)
- 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)
- 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.
- 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 :
- 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
Eligibility Criteria
| Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Contacts
| 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
| 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
Fonds National de la Recherche Scientifique
BESPEED
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 3, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | November 20, 2020 | ||||||||
| Actual Study Start Date ICMJE | June 15, 2019 | ||||||||
| Estimated Primary Completion Date | June 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Phenotypic and Genotypic Characterization of New-onset Type I Diabetes | ||||||||
| Official Title ICMJE | Phenotypic and Genotypic Characterization of a Cohort of Pediatric Patients With New-onset Type 1 Diabetes | ||||||||
| 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 :
|
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Type1diabetes | ||||||||
| Intervention ICMJE | 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
|
||||||||
| Study Arms ICMJE | Experimental: New-onset Type 1 diabetes
Intervention: Other: Glucagon
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 30, 2022 | ||||||||
| Estimated Primary Completion Date | June 15, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 6 Months to 18 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Belgium | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04007809 | ||||||||
| Other Study ID Numbers ICMJE | DIATAG | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Université Catholique de Louvain | ||||||||
| Study Sponsor ICMJE | Université Catholique de Louvain | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Université Catholique de Louvain | ||||||||
| Verification Date | November 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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