COLCHICINE for Type 1 diabetes

Inclusion criteria

• {"criterion_text":"- Type 1 diabetes for at least 5 years"}
• {"criterion_text":"- Age 18-65 years"}
• {"criterion_text":"- HbA1c lower or equal to 100 mmol/mol"}
• {"criterion_text":"- High glycemic variability: coefficent of variation of at least 30%"}
• {"criterion_text":"- Use of continuous glucose monitor for at least 3 months prior to start of the study"}
• {"criterion_text":"- Refractive error between -6 and +6 Diopters (calculated as spherical equivalent and before any treatments)"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Changes in marker for (subclinical) diabetic retinopathy (vessel density on OCTA) during the study period","definition_or_measurement_approach":"Vessel density assessed using optical coherence tomography angiography (OCTA) as a marker for (subclinical) diabetic retinopathy during the study period."}

Secondary endpoints

• {"endpoint_text":"- Changes in markers for (subclinical) diabetic retinopathy (e.g. micro-aneurysms, thinning of retinal layers, foveal avascular zone) during the study period","definition_or_measurement_approach":"Retinal structural and lesion markers (examples listed) assessed during the study period (methods not further specified in JSON)."}
• {"endpoint_text":"- Changes in markers for (subclinical) diabetic nephropathy (plasma creatinine and urea, urinary microalbuminuria) during the study period","definition_or_measurement_approach":"Laboratory measures including plasma creatinine, urea, and urinary microalbuminuria collected during the study period."}
• {"endpoint_text":"- Changes in inflammatory parameters (e.g. circulating immune cell numbers and phenotypes, immune cell function, circulating inflammatory proteins including various pro-inflammatory cytokines, endothelial markers) during the study period","definition_or_measurement_approach":"Assessment of circulating immune cell counts/phenotypes, immune cell function assays, and circulating inflammatory proteins (specific assays not detailed in JSON)."}
• {"endpoint_text":"- Changes in glycemic variability markers (e.g. coefficient of variation, time in range, standard deviation) as measured by the glucose sensor during the study period","definition_or_measurement_approach":"Glycemic variability measured via continuous glucose monitor metrics (coefficient of variation, time in range, standard deviation) during the study period."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-09-2025

Latest Decision Or Authorization Date

13-10-2025

Processing Time Days

33

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands