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IRCT20180624040228N2 IRCT 2019-03-27 Yazd Diabetes Research Center Synbiotic and gut microbiome Effects of synbiotic supplement on microbiome, TNFa and expression of microRNA-126, microRNA-146a in T2DM patients 2019-04-20 anticipated 72 Complete https://irct.ir/trial/38371 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To assign individuals to the intervention and control groups, a random number table will be used. Stratified blocked randomization method will be used based on sex (male and female) and age (25-45 years and 45-65 years), so that the number of samples assigned to each of the groups will be equal, Blinding description: Capsules containing synthetic and placebo are similar in shape and appearance and the bottles of Capsules are the same (in terms of color and shape). A and B labels will be fixed on the bottles of Capsules by someone irrelevant to the entire study. participants and researchers will be blinded to the contents in the bottles through out the study. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: Intervention group: The intervention group will receive synbiotic capsules (containing probiotic, fructo-oligosaccharide as prebiotic, lactose, magnesium stearate, talc) containing 500 mg for 12 weeks twice a day. Intervention 2: Control group: The control group will receive placebo (lactose, magnesium stearate, talc) containing 500 mg for 12 weeks twice a day. 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 No more information
public Fahime Zeinali
Yazd Diabetes Research Center, Shahid Sadoughi Blvd
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3728 0228 fghzeinaly@ssu.ac.ir Yazd Diabetes Research Center scientific Hassan Mozaffari-Khosravi
Health Faculty, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blvd, Alam Sqrt 8915173160
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 mozaffari.kh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Men and women with type 2 diabetes (the minimum elapsed time of diagnosis is 3 months and diabetes treatment is started in person) Age range 25 to 65 years Glycosylated hemoglobin above 6.5% and below 8.5% BMI is between 25 and 35 25 years 65 years Both Using alternative therapies with hormone (Insulin, Corticosteroids) or vitamin supplements Chronic kidney, liver, pulmonary diseases. chronic or acute inflammatory diseases (especially acute Pancreatic inflammation and Endocarditis)Valvular disease of the heart. Irritable Bowel Syndrome. Allergic Diabetes complications (Nephropathy, Cardiomyopathy, Retinopathy, Diabetic foot ulcers) People with low immune system (Autoimmune)Pregnancy, Lactation Use of tobacco and alcohol Probiotic consumption or treatment with antibiotics within the past month Follow the unusual diet up to 1month before the study E11 Type 2 diabetes mellitus Prevention Placebo Intervention group: Intervention group: The intervention group will receive synbiotic capsules (containing probiotic, fructo-oligosaccharide as prebiotic, lactose, magnesium stearate, talc) containing 500 mg for 12 weeks twice a day. Control group: The control group will receive placebo (lactose, magnesium stearate, talc) containing 500 mg for 12 weeks twice a day. Gut microbiom. Timepoint: Before and immediately after the intervention. Method of measurement: Quantitative Real time Polymerase Chain Reaction (QPCR) and 16s rRNA sequencing. Expression of microRNA-126. Timepoint: Before and immediately after the intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR). Experation of microRNA-146a. Timepoint: Before and immediately after the intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR). Serum levels of tumor necrosis factor alpha. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit. Triglyceride. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test. Total cholesterol. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test. High-density lipoprotein. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test. Low-density lipoprotein. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test. Fasting Blood Sugar. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test. Glycosylated hemoglobin. Timepoint: Before and immediately after the intervention. Method of measurement: Enzymatic Assay Kit. Fasting insulin. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit. Yazd University of Medical Sciences Yazd Diabetes Research Center Yazd University of Medical Sciences Approved 2019-03-08 Ethics committee of Shahid Sadoughi University of Medical Sciences Health Faculty, Shahid Sadoughi University of Medical Sciences, Shohadaye gomnam Blvd, Alam Sqrt yazd Yazd Iran (Islamic Republic of)