Prebiotics in Newly Diagnosed Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title: Effect of Prebiotic Fibre on Glycemic Control, Gut Microbiota, and Intestinal Permeability in Newly Diagnosed (<12 Months) Type 1 Diabetes

Status Recruiting

Clinical Trial Summary

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 newly diagnosed (<12 months) 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.

Clinical Trial Description

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 newly diagnosed (<12 months) 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). ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT04963777
• Study type: Interventional
• Source: University of Calgary
• Contact: Raylene A Reimer, PhD, RD
• Phone: 403-220-8218
• Email: reimer@ucalgary.ca
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2022
• Completion date: September 1, 2026