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

Diabetes Obes Metab. 2019 Jul;21(7):1642-1651. doi: 10.1111/dom.13702. Epub 2019 Apr 2.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Intramural

MeSH terms

  • Adult
  • Anti-Inflammatory Agents* / adverse effects
  • Anti-Inflammatory Agents* / pharmacology
  • Anti-Inflammatory Agents* / therapeutic use
  • Blood Glucose / analysis
  • Blood Glucose / drug effects
  • C-Reactive Protein / analysis
  • Colchicine* / adverse effects
  • Colchicine* / pharmacology
  • Colchicine* / therapeutic use
  • Female
  • Humans
  • Insulin / blood
  • Insulin Resistance / physiology
  • Male
  • Metabolic Syndrome* / complications
  • Metabolic Syndrome* / drug therapy
  • Middle Aged
  • Obesity / complications
  • Pilot Projects

Substances

  • Anti-Inflammatory Agents
  • Blood Glucose
  • Insulin
  • C-Reactive Protein
  • Colchicine