Prebiotics in Patients With Type 1 Diabetes

Официальное название

Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Type 1 Diabetes

Обзор

Evidence suggests that prebiotic fibre can correct dysbiosis, reduce intestinal permeability and improve glycemic control. The investigators hypothesize that microbial changes induced by prebiotics contribute to gut and endocrine adaptations that reduce glucose fluctuations, including less hyper- and hypoglycemia in type 1 diabetes (T1D). The primary objective is to compare the change in frequency of hypoglycemia from baseline to 6 months in n=144 individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin. Secondary objectives will be aimed at understanding the mechanisms by which the prebiotics could affect glycemic control.

Подробное описание

The investigators hypothesize that, as an adjunct to insulin, prebiotic supplementation will reduce the frequency of hypoglycemia and improve glycemic variability that is accompanied by enhanced serum C-peptide levels, a reduction in intestinal permeability and systemic inflammation, and altered gut microbiota.

Primary Objective To compare the change in frequency of hypoglycemia from baseline to 6 months in individuals with T1D treated with a 6-month course of prebiotic or placebo as an adjunct to insulin.

Secondary Objectives

1. To determine the change in glycemic variability and glycemic control using Continuous Glucose Monitor (CGM) metrics including: percentage change in Time In-, Below-, and Above-Range (i.e. TIR, TBR, and TAR) and A1C from baseline to 6 months in those treated with prebiotic or placebo. 2. To compare the change in stimulated C-peptide and pro-insulin from baseline to 6 months. 3. To determine the change in IP from baseline to 6 months. 4. To determine the change in serum inflammatory markers (IL-6, IFN-gamma, TNF, C-reactive protein, and IL-10). 5. To examine quality of life (QOL) and fear of hypoglycemia ratings, and adverse reactions (severe hypoglycemia, diabetic ketoacidosis, side effects). 6. To examine prebiotic-induced changes in gut microbiota composition and function (shotgun sequencing) and their metabolic by-products (fecal and serum metabolomics). 7. To compare the change in frequency of hypoglycemia from baseline to 9 months to determine persistence of effects post-intervention. 8. To determine the change in glycemic variability from baseline to 9 months to determine persistence of effects post-intervention.

Вмешательства

• Пищевая добавка Prebiotic
  Chicory root derived inulin-type fructan (13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ages ≥14 years)
• Пищевая добавка Placebo
  Maltodextrin (isocaloric; 13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ≥14 years)

Первичные конечные точки

• Change in frequency of hypoglycemia [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Change in glycemic variability [Срок оценки: 6 months]
• Change in glycemic control [Срок оценки: 6 months]
• Change in stimulated C-peptide [Срок оценки: 6 months]
• Change in serum proinsulin [Срок оценки: 6 months]
• Change in Intestinal permeability [Срок оценки: 6 months]
• Change in lipopolysaccharide [Срок оценки: 6 months]
• Change in Inflammatory marker IL-6 [Срок оценки: 6 months]
• Change in Inflammatory marker IFN-γ [Срок оценки: 6 months]
• Change in Inflammatory marker TNF [Срок оценки: 6 months]
• Change in Inflammatory marker CRP [Срок оценки: 6 months]
• Change in Inflammatory marker IL-10 [Срок оценки: 6 months]
• Change in quality of life [Срок оценки: 6 months]

Критерии участия

Критерии включения

Lead Site:

• Diagnosed with type 1 diabetes (based on Diabetes Canada 2018 Clinical Practice Guideline diagnostic criteria) in the previous 12 months.
• Age 7 years and above (as per our pilot trial and able to complete the required tests).

Subsites:

• Diagnosed with type 1 diabetes (based on Diabetes Canada 2018 Clinical Practice Guideline diagnostic criteria) in the previous 12 months.
• Age 7 to 17 years of age.

Критерии исключения

• Regular use of medications or supplements that could affect gut microbiota (examples: antibiotics, probiotic or prebiotic supplements, laxatives) within 3 months prior to enrollment.
• Previous intestinal surgery.
• Another chronic medical condition that could affect gut microbiota or intestinal permeability (examples: Crohn's disease, Celiac disease, colitis, irritable bowel syndrome)
• Presence of active infection, pregnancy or lactation.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

• University of Calgary — Calgary
• University of Alberta — Edmonton
• University of Saskatchewan — Saskatoon

Публикации

• Huang C, Rosolowsky E, Nour MA, Butalia S, Ho J, Mayengbam S, Wang W, Pyke S, Virtanen H, Reimer RA. Prebiotic supplementation in patients with type 1 diabetes: study protocol for a randomised controlled trial in Canada. BMJ Open. 2025 May 31;15(5):e102486. doi: 10.1136/bmjopen-2025-102486. PMID 40449951

Идентификаторы

NCT: NCT04963777 · REB21-0852

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗