The effects of melatonin supplementation on mean arterial pressure, pulse pressure, atherogenic index of plasma and new anthropometric index in type 2 diabetes mellitus patients

The purpose of this study is to investigate the effect of melatonin supplementation on mean arterial pressure, pulse pressure, atherogenic index of plasma and new anthropometric index in type 2 diabetes mellitus patients

In this double-blind, single-center clinical trial 50 diabetic patients are selected and randomly divided into two intervention (n=25) and control (n=25) groups. Randomization will be done using a block design method

This study will be done in diabetes clinic of Golestan Hospital, Ahvaz. The researchers and patients will not inform about the allocation of subjects in the groups (double-blinded). Anthropometric and blood pressure indices will measure before and after the intervention.

inclusion criteria: diagnosed diabetes more than 5 years, aged 30-60 years. Exclusion criteria; Unwillingness to participate in the study, complications of diabetes mellitus such as kidney failure, insulin-dependent diabetic patients, pregnancy, lactation, travel for more than 2 weeks, smokers, use of food supplements, probiotics and anti-inflammatory drugs, as well as Using any antioxidant supplements in the last 3 months, using immunosuppressive medications, following specific diets, change of diet or deciding to lose weight in the last 6 months.

The intervention group will receive two 3 mg Melatonin tablets (Nature Made, USA) per day, one hour before bedtime, for 60 days. The control group will receive two 3 mg placebo tablets (provided by Faculty of Pharmacy in Ahvaz Jundishapur University of Medical Sciences) containing cellulose, silicon dioxide,and starch one hour before bedtime, for 60 days.

Mean arterial pressure, pulse pressure, atherogenic index of plasma, a body shape index, abdominal volume index, body adiposity index, lipid accumulation product

Based on inclusion criteria, 50 patients will be randomly allocated to placebo (n = 25) or intervention (n = 25) groups. Block design based on the combined analysis will be used for randomization. In fact, according to pattern and using two codes of A and B 6 groups with 4 blocks will be select. This work is repeated in 2 steps. At the end, two A and B codes will be assign to the 2 last people and the randomization will be complete (50 patients).

Patients with type 2 diabetes who go to the diabetes Clinic of Department of Golestan Hospital are selected. Participants in this study and person who responsible for data collection are not aware of the type of drug used. َAlso, the researchers and patients are not aware of the contents of the packets (a double-blind). The coding in this study will be done by a person outside the study who has information about diabetes and knows what code is related to supplement and which is related to placebo. But do not have much information about the details of our research methods.

Due to the financial support of this research by the Ahvaz Jundishapur University of Medical Sciences , data of the study will be published after the end of the intervention as an article.