Actively Recruiting
Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2025-01-13
1000
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
C
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
The GLUREDIA study investigates the counter-regulatory response (CRR) during hypoglycemia in children with type 1 diabetes (T1D). Hypoglycemia can lead to severe symptoms, but is normally counteracted by CRR, corresponding to the secretion of hormones to maintain normoglycemia. Hypoglycemia is common in T1DM but some patients develop severe hypoglycemia as a result of CRR dysfunction. Despite several studies in adults, the presence of CRR dysfunction remains unpredictable and not well understood. The objective of GLUREDIA is therefore to describe and predict the evolution of CRR in children with T1DM.
CONDITIONS
Official Title
Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of new-onset type 1 diabetes according to ISPAD criteria
- Symptoms of high blood sugar such as increased urination, thirst, weight loss, or ketoacidosis
- Fasting blood glucose of at least 126 mg/dL and/or blood glucose of at least 200 mg/dL during an oral glucose tolerance test at 120 minutes and/or HbA1c of at least 6.5% and/or random blood glucose of at least 200 mg/dL with hyperglycemia symptoms
- Presence of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
- Age between 2 and 30 years
- Minimum weight of 17 kg for blood sampling
- Male or female patients
- Ability to provide free, written, and oral consent
You will not qualify if you...
- Age under 2 years
- Use of treatments interfering with insulin secretion or sensitivity (e.g., sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins)
- Newly diagnosed celiac disease within the past month
- Presence of autoimmune or autoinflammatory diseases other than type 1 diabetes or active cancer
- Obesity defined as BMI z-score greater than +3 SD
- Liver, kidney, or adrenal insufficiency
- History of bone marrow transplantation
- History of diabetes after hemolytic-uremic syndrome
- Epilepsy
- Absence of anti-islet autoantibodies
- Dysmorphia with suspected genetic syndrome
- Participation in another clinical study within the last 3 months involving blood derivatives or immunomodulating treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinique Universitaires Saint Luc
Brussels, Woluwe-saint-lambert, Belgium, 1200
Actively Recruiting
Research Team
P
Philippe Lysy, Pr
CONTACT
A
Antoine Harvengt, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
7
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