| Revision date | Field name | Previous value |
|---|---|---|
| October 8, 2017 | Secondary outcome 4 | Total antioxidant capacity |
| October 8, 2017 | Secondary outcome method of measurement 4 | Spectrophotometry |
| October 8, 2017 | Secondary outcome 6 | Glutathione |
| October 8, 2017 | Secondary outcome method of measurement 6 | Spectrophotometry |
| October 8, 2017 | Secondary outcome method of measurement 6 | Spectrophotometry |
| October 7, 2017 | Primary outcome measure 2 | Insulin resistance |
| October 5, 2017 | summary | Objective: The aim of this study is to determine the effects of melatonin supplementation on metabolic profiles in type 2 diabetes patients with coronary heart disease (CHD). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with CHD referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive melatonin supplement (n=30) or placebo (n=30). Melatonin and placebo capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial. |
| October 5, 2017 | Primary outcome measure 1 | Insulin |
| October 25, 2017 | Primary outcome method of measurement 1 | ELISA kit |
| October 25, 2017 | Primary outcome method of measurement 2 | Calculation using HOMA formula |
| October 25, 2017 | Secondary outcome 8 | Malondialdehyde |