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RECRUITING
NCT06770621
NA

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

Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2022-05-25

Completion Date

2025-10-25

Last Updated

2025-01-13

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Insulin-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_TEST

Glucagon 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)

OTHER

Biological sample once

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

OTHER

Observation-questionnaire

only the answer to a questionnaire

Locations (1)

Clinique Universitaires Saint Luc

Brussels, Woluwe-saint-lambert, Belgium