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

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

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus

Treatments: Dietary Supplement: Inulin (prebiotic, fermentable fiber); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07050888

2024.1028

Details and patient eligibility

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.

Full 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).

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

Inulin

Experimental group

Description:

prebiotic fermentable fiber inulin

Treatment:

Dietary Supplement: Inulin (prebiotic, fermentable fiber)

Placebo

Placebo Comparator group

Description:

Placebo: Maltodextrin

Treatment:

Dietary Supplement: Placebo