Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes mellitus, inulin, gut microbiome, prebiotics, CGM metrics, immunological parameters
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).
Interventions
DIETARY_SUPPLEMENTInulin (prebiotic, fermentable fiber)
inulin (prebiotic, fermentable fiber)
DIETARY_SUPPLEMENTPlacebo
placebo (matodextrin)
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
2x38 participants will be randomly allocated to inulin or placebo once daily for 90 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 90 days | Difference in time in range between the groups between baseline and end-of-study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition | 90 days | — |
| Residual beta cell function | 90 days | Changes in urinary C-peptide-to-creatinine-ratio (UCPCR) |
| 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. |
| Dietary intake | 90 days | Recorded of 3 days with Eetmeter. |
| Continuous glucose monitoring | 90 days | changes in glycaemic variability, time above range, time below range and hypoglycaemic episodes |
| CRP | 90 days | C-reactive protein (mg/L) |
| Leukocyte (differentation) | 90 days | ×10 9 /L |
| 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) |
| Quality of life questionnaire | 90 days | Quality of life SF-12 v2 questionnaire, a higher score reflects higher quality of life |
| Gut inflammation | 90 days | Fecal IgA and calprotectin in ug/g |
Countries
Netherlands
Contacts
Primary ContactNordin Hanssen, Principal Investigator
Outcome results
None listed