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New treatment option for Type 1 Diabetes Mellitus
Official title Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
ClinicalTrials.gov ID: NCT07050888
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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 likely can't join 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.