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

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT07050888
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

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).

Study Timeline

• Study Start: 2025-05-09
• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Immunological parameters	90 days	Plasma cytokines IFN-α, IFN-β, IFN-γ, IL-10 by ELISA
Gastrointestinal Symptom Rating Scale (GSRS)	90 days	Questionnaire. The minimum and maximum score are 15 and 105 points respectively, and a higher score in the scale reflects more gastro-intestinal complaints.
Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8	90 days	units per milliliter (U/mL)
HbA1c	90 days	Millimoles of HbA1c per mole of hemoglobin (mmol/mol)
Residual beta cell function	90 days	Changes in urinary C-peptide-to-creatinine-ratio (UCPCR)
Gut inflammation	90 days	Fecal IgA and calprotectin in ug/g
Quality of life questionnaire	90 days	Quality of life SF-12 v2 questionnaire, a higher score reflects higher quality of life
Continuous glucose monitoring	90 days	changes in glycaemic variability, time above range, time below range and hypoglycaemic episodes
Gut microbiome composition	90 days
Dietary intake	90 days	Recorded of 3 days with "Eetmeter".
CRP	90 days	C-reactive protein (mg/L)
Leukocyte (differentation)	90 days	×10 9 /L

Trial Locations

Locations (2)

Diabeter Centrum Amsterdam; 🇳🇱 Amsterdam, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands