Participants
T2DM
In a randomised, placebo-controlled, double-blind clinical trial, T2DM patients aged 30–60 years old from Firoozgar Hospital in Tehran, Iran, were recruited for the current study. The Ethics Committee of Iran University of Medical Sciences approved the study protocol, and the study protocol was registered on website of the the Iranian Registry of Clinical Trials (identifier: IRCT201410142709N31, at the date of 11/12/2014). All methods were performed in accordance with relevant guidelines and regulations of Helsinki declaration. According to the study by Fallah Huseini et al., this study was designed with a power of 90% and a two sided a = 0.05 (type I error) to detect a 5% difference in serum glucose between the two group. Based on the SDs observed in the current study, the number of subjects who needed treatment to detect this difference was 16/group. Considering an expected dropout rate of 25%, we set a target for enrollment of 20 subjects [