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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Canada
University of Calgary
RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
University of Saskatchewan
RECRUITING
Saskatoon
Contact Information
Primary
Raylene A Reimer, PhD, RD
reimer@ucalgary.ca
403-220-8218
Time Frame
Start Date: 2022-03-29
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 144
Treatments
Experimental: Prebiotic
Oligofructose-enriched inulin
Placebo_comparator: Placebo
Maltodextrin
Related Therapeutic Areas
Sponsors
Leads: University of Calgary

This content was sourced from clinicaltrials.gov

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