Prebiotic supplementation in patients with type 1 diabetes: study protocol for a randomised controlled trial in Canada
Bibliographic record
Abstract
Introduction Type 1 diabetes (T1D) mellitus is caused by autoimmune destruction of insulin-producing beta-cells, requiring exogenous insulin to sustain life. Achieving near normal blood glucose levels with insulin, a primary goal of diabetes management, carries a significant risk of hypoglycaemia. There is compelling evidence that an abnormal gut microbiota or dysbiosis can increase intestinal permeability (IP) and contribute to dysglycaemia seen in T1D. Given that prebiotic fibre can mitigate dysbiosis, reduce IP and improve glycaemic control, we hypothesise that microbial changes induced by prebiotics contribute to gut and endocrine adaptations that reduce glucose fluctuations, including less hypoglycaemia. In a pilot study, we showed that in children who had T1D for at least 1 year, a 3-month course of prebiotic fibre significantly reduced the frequency of hypoglycaemia. The prebiotic group had an increase in Bifidobacterium with a moderate improvement in IP. Importantly, the prebiotic group maintained their serum C peptide level (marker of residual beta cell function) while the placebo group saw a drop. Given that preserving endogenous beta cell function in patients with T1D, particularly in the first year of diagnosis, reduces hypoglycaemia and glycaemic variability, we propose to examine the effect of prebiotic supplementation in patients with T1D. Methods and analysis This is a multicentre, randomised, double-blind, placebo-controlled study. Individuals (n=144) with T1D will be randomised 1:1 for 6 months to prebiotic (oligofructose-enriched inulin) or placebo (isocaloric maltodextrin). Participants will have three in-person study visits at baseline, 3 months and 6 months. The primary outcome, frequency of hypoglycaemia, will be determined from continuous glucose monitor (CGM) reports and patient blood glucose logs. Secondary outcomes will include glycaemic variability, time-in-range, glycated haemoglobin, stimulated C peptide, IP, serum inflammatory markers, quality of life and fear of hypoglycaemia ratings, as well as gut microbiome and metabolomics analysis. At 9 months, participant CGM data will be used to assess frequency of hypoglycaemia and glycaemic variability at 3 months postintervention. Ethics and dissemination The study received ethical approval from the University of Calgary Conjoint Health Research Ethics Board (REB21-0852). The University of Alberta subsite was granted ethical approval under the province of Alberta’s research ethics reciprocity agreement as a participating site (REB21-0852; pSite00000066). The University of Saskatchewan subsite was granted ethical approval by the Biomedical Research Ethics Board (#4149). Trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number clinicaltrials.gov NCT04963777 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.011 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.010 | 0.006 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.047 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".