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Clinical Trials in the Netherlands / NCT07050888
Recruiting Not applicable

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

NCT07050888 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Not applicable
Started
2025-05-09
Last updated
2025-07-03

Condition(s) studied

Type 1 Diabetes Mellitus

Investigational drug(s) / intervention(s)

Inulin (prebiotic, fermentable fiber)Placebo

Inulin (prebiotic, fermentable fiber): inulin (prebiotic, fermentable fiber)

Placebo: placebo (matodextrin)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time in range — 90 days
    Difference in time in range between the groups between baseline and end-of-study

Trial sites (2)

FacilityCityRegionStatus
Diabeter Centrum Amsterdam Amsterdam Netherlands Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting

More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands

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Other trials for the same condition

A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes Recruiting
Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes Recruiting
Beta Cell Imaging During and Shortly After the Honeymoon Phase of T1D Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07050888 on ClinicalTrials.gov ↗ ← All trials in the Netherlands