Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)

Обзор

The goal is to establish the effect of oral inulin supplementation on continuous glucose monitoring (CGM) metrics and immunological parameters in adults with type 1 diabetes. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x38 participants to measure effects on CGM metrics, gut microbiome composition, residual beta cell and immunological parameters.

Подробное описание

The investigators perform a double-blind, randomized, placebo-controlled trial in 2x38 adults with type 1 diabetes. The participants will be given inulin or placebo once daily in powder, which can be dissolved in water and ingested orally, for 90 days. The main study endpoint is the difference in time in range between the groups between baseline and end-of-study. Secondary endpoints include changes in glycaemic variability, time in tight glycaemic range and hypoglycaemic episodes, gut microbiome composition, changes in residual beta cell function, changes in immunological parameters and validated questionnaires (Quality of Life and gastro-intestinal complaints).

Вмешательства

• Пищевая добавка Inulin (prebiotic, fermentable fiber)
  inulin (prebiotic, fermentable fiber)
• Пищевая добавка Placebo
  placebo (matodextrin)

Первичные конечные точки

• Time in range [Срок оценки: 90 days]

Вторичные конечные точки (12)

• Continuous glucose monitoring [Срок оценки: 90 days]
• Gut microbiome composition [Срок оценки: 90 days]
• Residual beta cell function [Срок оценки: 90 days]
• Immunological parameters [Срок оценки: 90 days]
• Gastrointestinal Symptom Rating Scale (GSRS) [Срок оценки: 90 days]
• Dietary intake [Срок оценки: 90 days]
• Gut inflammation [Срок оценки: 90 days]
• CRP [Срок оценки: 90 days]
• Leukocyte (differentation) [Срок оценки: 90 days]
• Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8 [Срок оценки: 90 days]
• HbA1c [Срок оценки: 90 days]
• Quality of life questionnaire [Срок оценки: 90 days]

Критерии участия

Критерии включения

• A diagnosis of type 1 diabetes, as made by their primary clinician
• A time in range of <80% in the last four weeks before screening

Критерии исключения

• Use of any fibre supplementation (within the last month before screening or ongoing)
• Use of antibiotics in the lasts three months before screening or during study period
• Active infection during the study visit
• Inability or unwillingness to donate feces or urine.
• Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
• Inability or unwillingness to provide informed consent.
• Absence of a large bowel (ie colostomy)
• Active inflammatory bowel disease

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• Diabeter Centrum Amsterdam — Amsterdam
• Amsterdam UMC — Amsterdam

Идентификаторы

NCT: NCT07050888 · 2024.1028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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