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

RECRUITINGN/ASponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Actively Recruiting
PhaseN/A
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Started2025-05-09
Est. completion2027-04
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07050888

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions2

DiabetesType 1 Diabetes Mellitus

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