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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04963777
Other study ID # REB21-0852
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 29, 2022
Est. completion date September 1, 2026

Study information

Verified date November 2023
Source University of Calgary
Contact Raylene A Reimer, PhD, RD
Phone 403-220-8218
Email reimer@ucalgary.ca
Is FDA regulated No
Health authority
Study type Interventional

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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date September 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility Inclusion Criteria: - Diagnosed with type 1 diabetes (based on Diabetes Canada 2018 Clinical Practice Guideline diagnostic criteria) in the previous 12 months. - Age 8 years and above (as per our pilot trial and able to complete the required tests). Exclusion Criteria: - 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.

Study Design


Intervention

Dietary Supplement:
Prebiotic
Chicory root derived inulin-type fructan (13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for ages =14 years)
Placebo
Maltodextrin (isocaloric; 13.2 kcal/day for ages 8-13 years; 26.4 kcal/day for =14 years)

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in frequency of hypoglycemia Blood glucose <3.9 mmol/L from continuous glucose monitor data 6 months
Secondary Change in glycemic control Glycated hemoglobin (A1C) 6 months
Secondary Change in stimulated C-peptide Serum collected during a mixed meal tolerance test 6 months
Secondary Change in Intestinal permeability Urinary lactulose/mannitol test 6 months
Secondary Change in Inflammatory marker IL-6 Serum IL-6 6 months
Secondary Change in quality of life Diabetes-specific quality of life survey 6 months
Secondary Change in dietary intake 24 hour dietary recall (energy intake, fat intake, carbohydrate intake, protein intake, fiber intake) 6 months
Secondary Change in gut microbiota composition Fecal microbiota taxonomy 6 months
Secondary Change in gut microbiota function Fecal microbiota shotgun sequencing 6 months
Secondary Change in serum metabolite concentration Serum LC-Qtof-Mass Spec metabolomics 6 months
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