Anti-inflammatory drug to prevent complications in type 1 diabetes
Key facts
- Where
- Nijmegen, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud universitair medisch centrum Stichting
- Trial code
- EU 2025-521397-34-00
- Record updated
- 2026. június 9.
- Original description
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.Read full original descriptionShow less
Colchicine to reduce microvascular complications in people with type 1 diabetes and high glycemic variability
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.
Inclusion: 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).
Exclusion: 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.