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Идёт набор NCT05594706

Anhydroglucitol in Children With Type 1 Diabetes

— Наблюдательное Diabetes Mellitus, Type 1

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Measurement of blood levels of 1,5-anhydroglucitol.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 1. Базовые параметры: 2 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
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Официальное название

Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study

Обзор

The investigators will measure blood levels of 1,5-anhydroglucitol in children with type 1 diabetes and correlate them with parameters related to functional beta-cell mass in diabetic patients. The values will be compared to those obtained in healthy volunteers. Children with newly diagnosed diabetes as well as children with longstanding disease will be included. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in type 1 diabetes.

Подробное описание

One-center prospective exploratory pilot study performed in collaboration between the Pediatric Endocrine and Diabetology unit of the University Hospitals of Geneva (HUG) and Prof. Pierre Maechler, Diabetes Center of the Faculty of Medicine, University of Geneva Switzerland.

1,5-anhydroglucitol (1,5-AG), a deoxyhexose present in almost all foods and forming a stable pool in human subjects, has recently been found to be correlated with functional beta-cell mass in two different mouse models of beta-cell dysfunction leading to diabetes. The decline of this biomarker precedes the development of hyperglycemia in lean b-Phb2 -/- and obese db/db diabetic mice, where beta-cell loss occurs through two different mechanisms.

Additional studies have shown a correlation of 1,5-AG levels with risk of progression of type 1 diabetes (T1DM) in auto-antibody positive children, as well as with glycaemic control in patients with type 2 diabetes.

The present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-AG in children with T1DM. This should contribute to the evaluation of a novel biomarker of beta-cell mass and function in T1DM.

Вмешательства

  • Другое Measurement of blood levels of 1,5-anhydroglucitol
    Measurement of blood levels of 1,5-anhydroglucitol

Первичные конечные точки

  • Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass [Срок оценки: Day 1]
  • Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass [Срок оценки: 4 months after diagnosis]
  • Correlation of 1,5-anhydroglucitol levels in newly diagnosed patients with indirect markers of beta-cell function and mass [Срок оценки: 12 months after diagnosis]
  • Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass [Срок оценки: In participants with a disease duration of 3 years.]
  • Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass [Срок оценки: In participants with a disease duration of 5 years.]
  • Correlation of 1,5-anhydroglucitol levels in patients with longstanding disease with indirect markers of beta-cell function and mass [Срок оценки: In participants with a disease duration of 10 years.]

Критерии участия

Критерии включения

  • Type 1 diabetes with positive autoantibodies against islets, insulin, islet antigen 2 (IA2), glutamic acid decarboxylase (GAD) 65 or zinc transporter (ZnT)8.
  • Treatment with continuous subcutaneous insulin infusion (CSII) with or without automated insulin delivery (AID).
  • Monitoring with a continuous glucose measurement system (CGMS) or flash glucose monitor (FGM).
  • Patient willing to keep the same type of CGMS or FGM during the year of observation
  • Ability to give informed consent as documented by signature

Критерии исключения

  • Patients treated with multiple daily injections (MDI) or not willing to wear a CGMS of FGM
  • Patients changing the type of CGMS during the course of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Швейцария · 1 центр
  • University Hospital of Geneva — Geneva

Идентификаторы

NCT: NCT05594706 · 2022-01684

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗