Colchicine to reduce microvascular complications in people with type 1 diabetes and high glycemic variability

Conditions

Type 1 Diabetes

Brief summary

Changes in marker for (subclinical) diabetic retinopathy (vessel density on OCTA) during the study period

Detailed description

Changes in markers for (subclinical) diabetic retinopathy (e.g. micro-aneurysms, thinning of retinal layers, foveal avascular zone) during the study period, Changes in markers for (subclinical) diabetic nephropathy (plasma creatinine and urea, urinary microalbuminuria) during the study period, 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, 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

Related papers

No related papers found yet.

Interventions

DRUGCapsules with microcrystalline cellulose

DRUGColchicine Teva 0

DRUG5 mg

DRUGtabletten

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Changes in marker for (subclinical) diabetic retinopathy (vessel density on OCTA) during the study period	—

Secondary

Measure	Time frame
Changes in markers for (subclinical) diabetic retinopathy (e.g. micro-aneurysms, thinning of retinal layers, foveal avascular zone) during the study period, Changes in markers for (subclinical) diabetic nephropathy (plasma creatinine and urea, urinary microalbuminuria) during the study period, 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, 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	—

Measure

Time frame

Changes in markers for (subclinical) diabetic retinopathy (e.g. micro-aneurysms, thinning of retinal layers, foveal avascular zone) during the study period, Changes in markers for (subclinical) diabetic nephropathy (plasma creatinine and urea, urinary microalbuminuria) during the study period, 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, 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

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Countries

Netherlands

Outcome results

None listed