Меню
Идёт набор NCT06682481

Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function

— Наблюдательное Obesity, Childhood Type 2 Diabetes Mellitus in Obese

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 biomarker.
Кому может быть актуально
Состояния в реестре: Obesity, Childhood, Type 2 Diabetes Mellitus in Obese. Базовые параметры: 12 лет — 16 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function: From Mice to Children

Обзор

The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. 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 children with obesity with or without type 2 diabetes.

Подробное описание

One-center prospective 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 (T2DM).

The present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-AG in children with obesity with or without T2DM. This should contribute to the evaluation of a novel biomarker of beta-cell mass and function in T2DM.

Вмешательства

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

Первичные конечные точки

  • Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control [Срок оценки: First oral glucose tolerance test]
  • Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control [Срок оценки: Second oral glucose tolerance test, 2 years after the first]
Вторичные конечные точки (2)
  • Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis [Срок оценки: First oral glucose tolerance test]
  • Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis [Срок оценки: Second oral glucose tolerance test, 2 years after the first]

Критерии участия

Критерии включения

  • Children aged 12 to 16 years
  • Obesity. Defined as a body-mass index above the 97th percentile.
  • Ability to give informed consent as documented by signature

Критерии исключения

  • Patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or Zinc transporter 8.
  • Patients with known liver disease (other than NAFLD)
  • Patients treated with an oral antidiabetic drug, glucagon-like peptide-1 analogues or insulin at the time of or less than 2 weeks prior to inclusion.
  • Patients treated with a drug known to affect liver function

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

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Швейцария · 1 центр
  • University Hospital of Geneva — Geneva

Идентификаторы

NCT: NCT06682481 · 2024-00031

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗