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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963777
• Other study ID #: REB21-0852
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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