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Taking people in NetherlandsPhase 4

Tests colchicine to study eye and kidney damage in type 1 diabetes

Tests colchicine in adults with type 1 diabetes and large blood sugar swings.

Key facts

Who runs it
Radboud universitair medisch centrum Stichting
Where
Nijmegen, NetherlandsSee the site
Registry title
Anti-inflammatory drug to prevent complications in type 1 diabetes
Status
Recruiting
Phase
Phase 4
People taking part
80 people, planned
Started
15 Dec 2025
Expected to end
1 Mar 2027
Type of study
Interventional
Record updated
9 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 diabetes whose blood sugar swings a lot. It tests whether colchicine affects early signs of eye and kidney damage from diabetes.

Age
18-70 years
Sex
All sexes can join.
Disease stage
Type 1 diabetes for at least 1 year. High blood sugar variability (coefficient of variation of at least 30%). HbA1c lower or equal to 100 mmol/mol (11.3%). Refractive error between -6 and +6 Diopters.
Earlier treatment
Must have used a continuous glucose monitor for at least 3 months before the start. Cannot have had retinal surgery, laser treatment of the retina, or eye injections with steroids or anti-VEGF drugs. Cannot have had other eye treatment in the past 3 months.
Biomarker or test result
Coefficient of variation of blood sugar of at least 30%. HbA1c lower or equal to 100 mmol/mol (11.3%).

Main reasons for not taking part

  • Pregnant, breastfeeding, or trying to conceive; male partners of women trying to conceive
  • Another auto-inflammatory or autoimmune disease (celiac disease, vitiligo, or well-treated thyroid disease are allowed)
  • Kidney disease (G3aA2 or worse), or moderate to severe liver disease
  • Proliferative diabetic retinopathy or diabetic macula edema
  • Use of colchicine or other anti-inflammatory drugs, or of drugs that are unsafe with colchicine

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Type 1 diabetes for at least 1 year
  • Age 18-70 years
  • HbA1c lower or equal to 100 mmol/mol
  • High glycemic variability: coefficent of variation of at least 30%
  • Use of continuous glucose monitor for at least 3 months prior to start of the study
  • Refractive error between -6 and +6 Diopters (calculated as spherical equivalent and before any treatments)

Who cannot take part

  • Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
  • Colchicine or other anti-inflammatory drug use
  • Active infection or illness in the past 14 days before blood collection (timing of blood collection can be adjusted)
  • Any vaccination in the past 4 weeks before blood collection (timing of blood collection can be adjusted)
  • Ophthalmological treatments in the past: retinal surgery, panretinal or focal laser photocoagulation, intravitreal injections with steroids or intravascular endothelial growth factor inhibitors
  • Any other ophthalmological treatments in the past 3 months prior to the start of the study or planned during the study period
  • Presence of other auto-inflammatory/-immune disease, except for celiac disease, vitiligo, or well-treated thyroid disease
  • Having moderate to severe hepatic disease
  • Current or history of alcohol and/or drugs abuse (i.e. >14 units per week)
  • Any other ophthalmological condition that can interfere with the diagnosis or progression of diabetic retinopathy (vascular occlusions, age-related macular degeneration, intra- or subretinal fluid, severe glaucoma, significant media opacities that hinder visualisation of the retina (e.g. mature cataract))
  • Women who are pregnant, breastfeeding, or trying to conceive in the period between the screening and until 3 months after the last study visit (self-reported)
  • Male partners of women trying to conceive in the period between the screening and until 6 months after the last study visit (self-reported)
  • Known blood dyscrasias
  • Nephropathy (G3aA2 or worse)
  • Habitual smoking, i.e. one or more cigarettes per day (in the last half year)
  • Proliferative diabetic retinopathy or presence of (diabetic) macula edema

Where in Netherlands

  • Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people

About the trial

What the trial wants to find out

The main objective of this trial is to determine whether colchicine can affect markers of microvascular complications (diabetic retinopathy and nephropathy) in people with type 1 diabetes and high glycemic variability.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Colchicine to reduce microvascular complications in people with type 1 diabetes and high glycemic variability
Plain-language title
Tests colchicine to study eye and kidney damage in type 1 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
9 June 2026