NCT07247734 The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation
| NCT ID | NCT07247734 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Asger Lund, MD |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12-22 |
Trial Parameters
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Brief Summary
The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.
Eligibility Criteria
Inclusion Criteria: * Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid \<200 pmol/L * Age 18-80 years * User of a continuous glucose monitor (CGM) system * Glycated hemoglobin A1c (HbA1c) 42-75 mmol/mol * Stable insulin therapy (defined as no change in insulin brand and no newly initiated Continuous subcutaneous insulin infusion (CSII) or Multiple dose injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitor or intermittently scanned continuous glucose monitor) ≥ 3 months with either multiple daily injections or continuous subcutaneous insulin infusion * Estimated glomerular filtration rate ≥ 60 mL/min/L/1.73 m² * Estimated glucose disposal rate (eGDR)\* \< 8 mg/kg/min OR insulin usage of ≥1 IU/kg pr day * C-reactive protein (CRP) hsCRP ≥ 2 mg/L, (measured by high-sensitivity assay)\*\* Exclusion Criteria: * Hypoglycaemia unawareness (inability to register low blood
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