RecruitingNot ApplicableNCT06770621

Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes

Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes (GLUREDIA Study): Characteristics and Predictive Biomarkers.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Enrollment

1,000 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Type1diabetes Severe Hypoglycemia

Summary

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.

Eligibility

Min Age: 2 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how the body's response to low blood sugar (hypoglycemia) — specifically the hormone glucagon, which normally raises blood sugar — changes over time in children and teenagers newly diagnosed with type 1 diabetes. Understanding this can help improve diabetes management in young patients. **You may be eligible if...** - You are a child or adolescent newly diagnosed with type 1 diabetes - You have symptoms of high blood sugar and meet the blood sugar criteria for type 1 diabetes **You may NOT be eligible if...** - You are under 2 years of age - You are taking medications that affect insulin secretion or sensitivity (such as corticosteroids, sulfonylureas, somatostatin, or biguanides) - You were recently diagnosed with celiac disease (within the past month) - You have another active autoimmune or inflammatory disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTInsulin-induced hypoglycemia test

For these tests, multiple blood samples will be collected during insulin-induced hypoglycemia (stage 1 hypoglycemia is defined as a blood glucose level below 70 mg/dL, while stage 2 corresponds to values below 54 mg/dL). The tests will be conducted on patients who have fasted for at least 12 hours and will be supervised by a medical staff member trained to manage severe hypoglycemia.

DIAGNOSTIC_TESTGlucagon profile

The subject must fast before the consultation and follow a specific diet the day before; after an initial blood draw (P1), the patient will have breakfast and take any required insulin, followed by two additional blood draws 1.5 hours after breakfast (P2) and 1.5 hours after P2 (P3)

OTHERBiological sample once

The exome of each patient will then be analyzed from the blood sample taken beforehand.

OTHERObservation-questionnaire

only the answer to a questionnaire

Locations(1)

Clinique Universitaires Saint Luc

Brussels, Woluwe-saint-lambert, Belgium

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NCT06770621

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