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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT07050888

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

76

Starts

2025-05-09

Expected to finish

2027-04-01

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Diabeter Centrum Amsterdam — Amsterdam, Netherlands (enrolling)
• Amsterdam UMC — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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