Actively Recruiting
Longitudinal Study of the Glucagon Response to Hypoglycemia in Children and Adolescents With New-onset Type 1 Diabetes (GLUREDIA Study): Characteristics and Predictive Biomarkers
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 is focused on children and adolescents with new-onset type 1 diabetes (T1D) to understand how their bodies respond to low blood sugar (hypoglycemia). The study explores the counter-regulatory response (CRR), which involves hormone secretion to maintain normal blood sugar levels. Hypoglycemia is common in T1D, but some children experience severe symptoms due to problems with CRR, which are not well understood, especially in younger patients. This research aims to describe and predict how CRR changes over time in this population. Participants undergo several diagnostic tests including an insulin-induced hypoglycemia test where blood samples are taken during low blood sugar stages under medical supervision. Another test tracks glucagon levels after fasting and following a controlled breakfast with blood draws at specific intervals. Biological samples are collected once for genetic analysis, and participants complete questionnaires to provide additional information. These tests and assessments are repeated over an 18-month period to monitor changes. Throughout the study, children and adolescents will have multiple visits for blood sampling and monitoring of their pancreatic alpha-cell function and related blood biomarkers. Researchers will track the evolution of their hormone responses to hypoglycemia. Safety measures include medical supervision during tests and adherence to fasting and dietary instructions. The total participation time for each patient is about 18 months, during which the study carefully evaluates their hormonal responses and blood markers to better understand hypoglycemia management in young people with T1D.
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
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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
A
Antoine Harvengt, Dr
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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