Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
INCREASE
1 other identifier
interventional
76
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2025
CompletedFirst Submitted
Initial submission to the registry
June 6, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
July 3, 2025
June 1, 2025
1.9 years
June 6, 2025
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in range
Difference in time in range between the groups between baseline and end-of-study
90 days
Secondary Outcomes (12)
Continuous glucose monitoring
90 days
Gut microbiome composition
90 days
Residual beta cell function
90 days
Immunological parameters
90 days
Gastrointestinal Symptom Rating Scale (GSRS)
90 days
- +7 more secondary outcomes
Study Arms (2)
Inulin
EXPERIMENTALprebiotic fermentable fiber inulin
Placebo
PLACEBO COMPARATORPlacebo: Maltodextrin
Interventions
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Diabeter Centrum Amsterdam
Amsterdam, 1066EC, Netherlands
Amsterdam UMC
Amsterdam, 1105 AZ, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nordin Hanssen, Principal Investigator
Amsterdam UMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The unblinded researcher will provide the study intervention to the blinded investigator in a coded fashion. Both the investigator and the participant are blinded. In case of emergency, an unblinding protocol is activated.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principial investigator
Study Record Dates
First Submitted
June 6, 2025
First Posted
July 3, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
July 3, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share