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IRCT20151128025274N6 IRCT 2021-01-10 Ahvaz University of Medical Sciences The effects of rutin supplement on the brain of type 2 diabetes mellitus patients The effects of rutin flavonoid supplement on brain white matter neural tracts volume in type 2 diabetes mellitus patients by MRI 2021-01-20 anticipated 26 Complete https://irct.ir/trial/53283 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Assignment of patients in each of the study groups (supplement or placebo) will be done by "Random allocation software" using classified randomized blocking method (block size: 4). In addition, in order to reduce selection bias error, allocation concealment will be used. This will be done by assigning unit codes (two codes A and B) to each patient's tablets. In this way, 26 patients will be randomly allocated to placebo (n = 13) or intervention (n = 13) groups. In fact, each patient will receive a can containing code A or B, and eventually 13 patients will receive cans containing code A and 13 patients will receive cans containing code B, Blinding description: In the present study, the doctor, researcher, and patients will be blinded to the study groups. Before starting the study, the cans containing the respective tablets will be coded by a person other than the researcher (this person will not aware of the details of the research) to A and B, so that the type of received tablets in each group will be blinded for researcher. Also, placebo and supplement tablets will be similar in terms of color, shape, size and taste. In addition, cans containing the supplement and placebo will be quite similar. 2 Type 2 diabetes mellitus. Intervention 1: Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days. Intervention 2: Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics
public Hadi Bazyar
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz
Ahvaz Iran (Islamic Republic of) 7853167465 +98 61 3333 0747 hadibazyar2015@gmail.com Ahvaz University of Medical Sciences scientific Ahmad Zare Javid
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
Ahvaz Iran (Islamic Republic of) 6163764754 +98 74 3333 1257 ahmaddjavid@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study People between 20 to 60 years old in both sexes, Over at least 2 years from time of diagnosis of type 2 diabetes mellitus Body mass index (BMI) less than 35 (BMI ≤ 35) Glycosylated hemoglobin (HbA1c) between 6.5 to 11% 20 years 60 years Both Developing complications from diabetes such as renal failure Diabetic patients taking insulin Thyroid disease Anemia Pregnancy, lactation Smokers Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets other than the diet specific to diabetic patients, History of brain surgery and brain tumors. E11 Type 2 diabetes mellitus Treatment - Other Placebo Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), made by the Solgar company, USA, after meals for 90 days. Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), made by the Faculty of Pharmacy of Ahvaz Jundishapur University of Medical Sciences, in terms of shape, color, size similar to supplement, after meals for 90 days. Fractional anisotropy (FA). Timepoint: Before and after the intervention. Method of measurement: Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software. MD: Mean diffusivity. Timepoint: Before and after the intervention. Method of measurement: Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software. RD: Radial diffusivity. Timepoint: Before and after the intervention. Method of measurement: Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software. AD: Axial diffusivity. Timepoint: Before and after the intervention. Method of measurement: Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software. The volume of white matter of the throwing, radial and communication fibers of the brain. Timepoint: Before and after the intervention. Method of measurement: Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software. The volume of gray matter of the brain. Timepoint: Before and after the intervention. Method of measurement: Using Diffusion Tensor Imaging (DTI) and analysis with functional magnetic resonance imaging of the brain software library (FSL) software. Ahvaz University of Medical Sciences Approved 2020-12-26 The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz Khouzestan Iran (Islamic Republic of)