Safety and Efficacy of Melatonin in the Lipid Profile of Patients with Type 2 Diabetes Mellitus: A Randomized Clinical Trial

Melatonin is available as a dietary supplement and is frequently used for sleep disorders. Decrease in cholesterol absorption, increase in LDL oxidation, and decrease in free fatty acids have been associated with melatonin use. The present study aimed to evaluate the effects of melatonin on changes in the lipid profile of patients with type 2 diabetes mellitus.

This double-blind randomized clinical trial was conducted on patients with diagnosis of type 2 diabetes mellitus. They were allocated to receive either 6 mg/d of melatonin or placebo for a minimum of eight weeks. The levels of cholesterol, triglyceride, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) were evaluated at baseline and at the end of the study.

The demographic characteristics, baseline lipid profiles, and current medication use were found to be similar in the two groups, except for metformin use (100% vs. 86.11%; P=0.02). There was no significant difference between the two groups in terms of the lipid parameters, such as cholesterol, triglyceride, LDL, and HDL levels (P=0.26, 0.81, 0.21, and 0.66, respectively). There were no serious adverse drug reactions in the two groups during the study.

According to the results of this trial, 6 mg/d of melatonin does not change the lipid profile of patients with type 2 diabetes mellitus.