Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inulin (prebiotic, fermentable fiber), Placebo.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
The investigators perform a double-blind, randomized, placebo-controlled trial in 2x38 adults with type 1 diabetes. The participants will be given inulin or placebo once daily in powder, which can be dissolved in water and ingested orally, for 90 days. The main study endpoint is the difference in time in range between the groups between baseline and end-of-study. Secondary endpoints include changes in glycaemic variability, time in tight glycaemic range and hypoglycaemic episodes, gut microbiome composition, changes in residual beta cell function, changes in immunological parameters and validated questionnaires (Quality of Life and gastro-intestinal complaints).
Interventions
- Dietary supplement Inulin (prebiotic, fermentable fiber)
inulin (prebiotic, fermentable fiber) - Dietary supplement Placebo
placebo (matodextrin)
Primary outcome measures
- Time in range [Time frame: 90 days]
Secondary outcome measures (12)
- Continuous glucose monitoring [Time frame: 90 days]
- Gut microbiome composition [Time frame: 90 days]
- Residual beta cell function [Time frame: 90 days]
- Immunological parameters [Time frame: 90 days]
- Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: 90 days]
- Dietary intake [Time frame: 90 days]
- Gut inflammation [Time frame: 90 days]
- CRP [Time frame: 90 days]
- Leukocyte (differentation) [Time frame: 90 days]
- Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8 [Time frame: 90 days]
- HbA1c [Time frame: 90 days]
- Quality of life questionnaire [Time frame: 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Diabeter Centrum Amsterdam — Amsterdam
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT07050888 · 2024.1028