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Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)

RecruitingNAAges 18 Years - 70 YearsAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT07050888 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal is to establish the effect of oral inulin supplementation on continuous glucose monitoring (CGM) metrics and immunological parameters in adults with type 1 diabetes. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x38 participants to measure effects on CGM metrics, gut microbiome composition, residual beta cell and immunological parameters.

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📋 Eligibility rules (as published)
Inclusion Criteria: * A diagnosis of type 1 diabetes, as made by their primary clinician * A time in range of \<80% in the last four weeks before screening Exclusion Criteria: * Use of any fibre supplementation (within the last month before screening or ongoing) * Use of antibiotics in the lasts three months before screening or during study period * Active infection during the study visit * Inability or unwillingness to donate feces or urine. * Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period. * Inability or unwillingness to provide informed consent. * Absence of a large bowel (ie colostomy) * Active inflammatory bowel disease
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What it tests

  • Inulin (prebiotic, fermentable fiber)
  • Placebo
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Where

2 sites
Diabeter Centrum Amsterdam
Amsterdam, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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