The effects of melatonin administration on carotid intima-media thickness and pulse wave velocity in diabetic nephropathy: A randomized, double-blind, placebo-controlled trial

Previous studies have reported that melatonin intake is inversely associated with reduced markers of atherosclerosis development such as carotid intima-media thickness (CIMT).This study was designed to assess the effects of melatonin administration on CIMT and pulse wave velocity (PWV) in patients with diabetic nephropathy (DN).This randomized, double-blind, placebo-controlled trial was conducted on 32 DN patients. Subjects were assigned to receive melatonin or placebo (starch) for 24 weeks. Individuals in the melatonin group (n = 19) received 10 mg/day. CIMT and PWV levels were taken at the study baseline and after 24 weeks of intervention.After 24 weeks of intervention, melatonin intake did not affect mean levels of left (P = 0.51) and right (P = 0.16) CIMT and maximum levels of left (P = 0.76) and right (P = 0.15) CIMT, and PWV (P = 0.55) compared with the placebo. In addition, within-group difference demonstrated a significant reduction in mean levels of right CIMT (P = 0.01) in the melatonin group. We did not observe any significant change in C-reactive protein (CRP) concentrations after melatonin intake (P = 0.81).Melatonin intake did not affect mean levels of left and right CIMT and maximum levels of left and right CIMT, PWV, CRP levels compared with the placebo. In addition, within-group difference demonstrated a significant reduction in mean levels of right CIMT in the melatonin group. This trial was registered at www.irct.ir as http://www.irct.ir: IRCT20200527047584N2.