Inulin for blood sugar control and immune markers in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized, placebo-controlled trial enrolling 76 adults with type 1 diabetes who are randomized 1:1 to daily inulin powder or placebo for 90 days. The primary endpoint is change in time in range measured by continuous glucose monitoring from baseline to end of study, with secondary endpoints including glycaemic variability, time in tight range, hypoglycaemic episodes, gut microbiome composition, residual beta cell function, immunological parameters, and patient-reported quality of life and gastrointestinal symptoms. Participants provide stool and urine samples and undergo laboratory testing at baseline and end-of-study; recent antibiotic use or ongoing fibre supplementation are exclusion criteria. The trial is conducted at Amsterdam UMC/Diabeter in Amsterdam and uses validated CGM metrics and microbiome analyses to link dietary prebiotic exposure with metabolic and immune outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Diabeter Centrum Amsterdam
  Amsterdam, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Nordin Hanssen, Principal Investigator — Amsterdam UMC
• Study coordinator: Nordin Hanssen, Principal Investigator
• Email: n.m.j.hanssen@amsterdamumc.nl
• Phone: +31 20-5669111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Toronto and 1 other locations · NCT07831798

• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

  This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

  This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.

  Recruiting Phase 2/3 Ain Shams University · Cairo · NCT07804849

• Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches

  This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.

  Recruiting Steno Diabetes Center Copenhagen · Copenhagen · NCT07767461

• AI-assisted remote insulin pump optimization for people with type 1 diabetes

  This study tests an AI-powered tool that suggests insulin pump settings for people with type 1 diabetes, with doctor-approved recommendations delivered to a mobile app.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07732777

• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

  Recruiting Early Phase 1 ClinSurge Research · Toronto, Ontario · NCT07655076

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.