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Prebiotics in Newly Diagnosed Type 1 Diabetes

Type 1 Diabetes

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    8 and up

Participation Criteria

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 Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Raylene A Reimer, PhD, RD

[email protected]
403-220-8218
Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: NCT04963777