Efficacy of low-dose colchicine on arterial stiffness via cardio-ankle vascular index in type 2 diabetes: a randomized controlled trial

Background Diabetes mellitus is associated with increased arterial stiffness and elevated cardiovascular risk. Colchicine reduces vascular inflammation by inhibiting the NLRP3 inflammasome, lowering IL-1β and IL-18. The cardio-ankle vascular index (CAVI) is a blood pressure-independent parameter that is used to evaluate arterial stiffness. Efficacy of colchicine in improving arterial stiffness in DM patient is not clearly established. Purpose To evaluate the effect of low-dose colchicine on arterial stiffness measured by CAVI in patients with T2DM. Methods This prospective, randomized, double-blind, placebo-controlled trial enrolled patients with T2DM aged 40 to 60 years meeting one of the following conditions: hyperlipidemia, hypertension, obesity defined as BMI greater than 25 kg/m2 or a waist circumference greater than 90 cm in males, or 80 cm in females and without established atherosclerotic cardiovascular disease. Participants were randomized (1:1) to receive low dose colchicine (0.6 mg daily) or a matching placebo for 6 months. The primary endpoint was the mean change in CAVI from baseline to 6 months. Secondary endpoints included changes in high-sensitivity C-reactive protein (hs-CRP), metabolic parameters, and adverse events. Analysis was performed on an intention-to-treat basis. Results A total of 60 patients were randomized (mean age 53.2 years; 40% male). Baseline clinical characteristics and CAVI scores were well-matched between the colchicine (7.86 ± 0.92) and placebo (7.89 ± 1.02) groups except prevalence of hypertension. At 6 months, the absolute change in CAVI did not differ significantly between groups. The mean change in CAVI from baseline to month 6 was 0.17 (95% CI: -0.10 to 0.44) in the colchicine group compared to 0.01 (95% CI: -0.29 to 0.30) in the placebo group (between group difference 0.17, 95% CI: -0.18 to 0.51, p=0.35). Similarly, mean changes in hs-CRP did not differ significantly (0.42 vs 0.25 mg/L, p=0.78). No significant interactions were observed across subgroups stratified by age, sex, or diabetes duration. Adverse events were rare, primarily consisting of mild gastrointestinal side effects; no adverse effects prompted discontinuation of the study drug. Conclusion In adults with T2DM, low-dose colchicine did not result in a significant improvement in arterial stiffness as measured by CAVI at 6 months. Inflammatory markers also showed no significant interval change. These findings suggest that short-term, low-dose colchicine administration may be insufficient to reverse established arterial stiffness in this population; longer follow-up and larger study populations may be needed to confirm these findings.baselineoutcome