Actively Recruiting
Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-07-03
76
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Diabeter Centrum Amsterdam
Amsterdam, Netherlands, 1066EC
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
Research Team
N
Nordin Hanssen, Principal Investigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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