Low-dose Colchicine in Type 2 Diabetes with Microalbuminuria: A Double-blind Randomized Clinical Trial.

BACKGROUND Neutrophil-related chronic inflammation (NRCI) may contribute to the pathogenesis of diabetic kidney disease (DKD). We evaluated whether blocking NRCI with a low-dose colchicine prevents DKD. METHODS A double-blind, randomized, placebo-controlled study was conducted. A total of 160 Patients with type 2 diabetes (T2D) and microalbuminuria (urinary albumin creatinine ratio [UACR] 30 to 300 mg/g Cr) who received angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) for at least 3 months were included. Subjects were 1:1 randomized to a placebo or colchicine group (0.5 mg/day). RESULTS The primary endpoint was the incidence of overt nephropathy (UACR>300 mg/g Cr). During the 36 months, 38 patients (51.4%) in colchicine group and 39 (54.1%) in the control group developed overt nephropathy (HR = 1.066; 95%CI = 0.679 to 1.673; P = 0.78). Compared with placebo, colchicine modestly lowered levels of NRCI parameters (P values <0.05 for hs-CRP, WBCC, NC and NLR), while the changes of UACR and estimated glomerular filtration rate (eGFR) were similar between the two groups. There were no significant differences between two groups in drug-related adverse events, including infection, gastrointestinal symptoms and limb numbness. CONCLUSIONS In patients with T2D with microalbuminuria, low-dose colchicine effectively and safely lowered NRCI but did not prevent the incidence of overt nephropathy. This article is protected by copyright. All rights reserved.