Effects of colchicine in adults with metabolic syndrome: A pilot randomized controlled trial

Abstract

Aim: To evaluate the efficacy and safety of colchicine for improving metabolic and inflammatory outcomes in people with obesity and metabolic syndrome (MetS).

Materials and methods: Adults with obesity and MetS, but who did not have diabetes, were randomized to colchicine 0.6 mg or placebo capsules twice daily for 3 months. The primary outcome was change in insulin sensitivity (SI ) as estimated by insulin-modified frequently sampled intravenous glucose tolerance tests. Secondary outcomes included changes in other metabolic variables and inflammatory markers.

Results: Of 40 participants randomized (21 colchicine, 19 placebo), 37 completed the trial. Compared with placebo, colchicine significantly reduced C-reactive protein (P <0.005), erythrocyte sedimentation rate (P <0.01), white blood cell count (P <0.005), and absolute neutrophil count (P <0.001). Change in SI was not significantly different between colchicine and placebo arms (difference: +0.21 × 10-5 ; CI -1.70 to +2.13 × 10-5 min-1 mU-1 mL; P = 0.82). However, changes in some secondary outcomes, including homeostatic model assessment of insulin resistance (P = 0.0499), fasting insulin (P = 0.07) and glucose effectiveness (P = 0.08), suggested metabolic improvements in the colchicine versus placebo group. Adverse events were generally mild and similar in both groups.

Conclusions: This pilot study found colchicine significantly improved obesity-associated inflammatory variables and showed a good safety profile among adults with obesity and MetS who did not have diabetes. These results suggest a larger, adequately powered study should be conducted to determine whether colchicine improves insulin resistance and other measures of metabolic health in at-risk individuals.

Keywords: beta-cell function; inflammation; insulin resistance; insulin sensitivity; obesity.

Published 2019. This article is a U.S. Government work and is in the public domain in the USA.

Figures

Figure 1.

CONSORT flow diagram of participants during the trial.

Figure 2.

Metabolic and inflammatory changes after three months of study medication in participants randomized to colchicine (N=21) or placebo (N=19). A: Insulin sensitivity (SI); B: fasting glucose; C: fasting insulin; D: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR); E: high sensitivity C-reactive protein (hsCRP); F: erythrocyte sedimentation rate (ESR); G: white blood cell count (WBC); H: neutrophil count; and I: platelet count. Data are presented as mean ± SEM.