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IRCT20171118037528N1 IRCT 2017-12-29 Yazd University of Medical Sciences Effect of resveratrolon vascular function Effects of resveratrol on lipid and glycemic profile indices, expression of PPARα, some factors associated with cell cycle arrest and sCD163 to sTWEAK ration in T2DM patients. 2018-07-21 anticipated 72 Complete https://irct.ir/trial/27734 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified blocked randomization method will be used based on sex (male and female) and age (30-45 years and 45-60 years). To assign individuals to the intervention and control groups, a random number table will be used, Blinding description: Supplements and placebos will be provided in the same appearance and shape and they will be packed in the same bottles, and the only difference will be the letters (A and B) on the bottles. Labels will be affixed to the bottles by someone who is not related to the study. Each bottle contains 120 capsules (for one-month usage). Participants and administrators will be unaware about the contents in the bottles. 2 Type 2 diabetes mellitus. Intervention 1: Patients in the intervention group will receive two capsules of 500 milligrams of resveratrol per day in 8 weeks. Intervention 2: Patients in the control group will receive two capsules of 500 milligrams of methyl cellulose per day in 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet.
public ُShima Abdollahi
Safaeiye Ave., Alam Square., Shahid Sadoughi University of Medical Science
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3149 2241 sh-abdollahi@razi.tums.ac.ir Yazd University of Medical Sciences scientific Hassan Mozaffari Khosravi
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3149 2241 mozaffari.kh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Male and female subjects with established T2DM, who have been diagnosed for at least three months who have body mass index between 24-30 kgm2, and aged 30-60 years, 30 years 60 years Both clinical diagnosis of any liver, kidney, cancer and Alzheimer's diseases insulin therapy; HbA1c≥ 8% consumption of any antioxidant supplements in the last six months history of allergic reaction to grapes; consumption of anticoagulants, fibrates and aspirin drinking red wine and alcohol history of myocardial infraction presence of stent or battery in the heart gastrointestinal ulcer pregnancy or lactation; follow the unusual diet until one month before the study; unwillingness to participation in study E11 Type 2 diabetes mellitus Prevention Placebo Patients in the intervention group will receive two capsules of 500 milligrams of resveratrol per day in 8 weeks. Patients in the control group will receive two capsules of 500 milligrams of methyl cellulose per day in 8 weeks. Proxisome proliferatore activated receptor alpha. Timepoint: Before and after intervention. Method of measurement: Gene expression. P53 gene. Timepoint: Before and after intervention. Method of measurement: Gene expression. P21 gene. Timepoint: Before and after intervention. Method of measurement: Gene expression. P16 gene. Timepoint: Before and after intervention. Method of measurement: Gene expression. Soluble Cluster of Differentiation 163. Timepoint: Before and after intervention. Method of measurement: Serum concentration using kit and The enzyme-linked immunosorbent assay method. TNF-related weak inducer of apoptosis. Timepoint: Before and after intervention. Method of measurement: Serum concentration using kit and The enzyme-linked immunosorbent assay method. Paraoxonase1 activity. Timepoint: Before and after intervention. Method of measurement: Serum concentration using kit and The enzyme-linked immunosorbent assay method. Asymmetric de-methyl arginine. Timepoint: Before and after intervention. Method of measurement: Serum concentration using kit and The enzyme-linked immunosorbent assay method. Total Triglyceride. Timepoint: Before and after intervention. Method of measurement: Turbidometry. Total cholesterol. Timepoint: Before and after intervention. Method of measurement: Turbidometry. High density lipoprotein Cholesterol. Timepoint: Before and after intervention. Method of measurement: Turbidometry. Low density lipoprotein Cholesterol. Timepoint: Before and after intervention. Method of measurement: Turbidometry. Fasting blood glucose. Timepoint: Before and after intervention. Method of measurement: Turbidometry. Glycated hemoglobin. Timepoint: Before and after intervention. Method of measurement: Enzymatic kit. Fasting insulin. Timepoint: Before and after intervention. Method of measurement: The enzyme-linked immunosorbent assay. Lipid Accumulation Product. Timepoint: Before and after intervention. Method of measurement: Formula. Visceral adiposity index. Timepoint: Before and after intervention. Method of measurement: Formula. Castelli 1 index. Timepoint: Before and after intervention. Method of measurement: Formula. Castelli 2 index. Timepoint: Before and after intervention. Method of measurement: Formula. Atherogenic Coefficient. Timepoint: Before and after intervention. Method of measurement: Formula. Iran National Science Foundation Yazd University of Medical Sciences Iran National Science Foundation Approved 2017-10-23 Ethics committee of Shahid Sadoughi University of Medical Science Safaeiye Ave., Alam Square., Shahid Sadoughi University of Medical Science., Yazd. Yazd Yazd Iran (Islamic Republic of)