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IRCT20221120056553N1 IRCT 2022-11-30 Shahid Beheshti University of Medical Sciences Effect of probiotic in predaibetes Evaluation of metabolic effects of probiotic supplementation on adults with pre-diabetic state 2022-12-06 anticipated 80 Complete https://irct.ir/trial/66963 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sequence generation will be done by simple randomization and preparing and shuffling cards, so that 80 cards (40 cards with the symbol A and 40 cards with the symbol B) will be prepared and will be placed inside Sequentially Numbered Opaque Sealed Envelops (SNOSE) and will been shuffled. According to arrival eligible patients will choose an envelope, so that the relevant group is determined(patients will be unaware of each other's assigned group). The selected envelope will be separated from the rest of the envelopes. This process will be continued until the 80th patient, so that finally 40 patients will be placed in the intervention group and 40 patients in the control group, Blinding description: In this study, the main researcher, doctor and the person responsible for analysis the statistical data will be blinded , and the medication will be given to patient by a nurse.Also, patients will be unaware of which type of medicine they are taking (probiotic or placebo). 2-3 Condition 1: pre-diabetic state. Condition 2: pre-diabetic state. Intervention 1: Intervention group: Pre diabetic patients receiving probiotic medicine under trade name Biodiab ,a product of Novagen pharmaceutical company with Tekgene Holding, every 12 hours for 3 months. According to the duration of the study, 180 capsules have been prepared for each person. Intervention 2: Pre diabetic patients receiving placebo, a maltodextrin composition , under trade name Biodiab ,a product of Novagen pharmaceutical company with Tekgene Holding, every 12 hours for 3 months, placebo in shape size color and packing is as same as probitic. According to the duration of the study, 180 capsules have been prepared for each person. Yes - There is a plan to make this available What will be shared: The data spss file includes groups and main and demographic variables When: After publication the article extracted from the plan To whom: Those who have corresponded with the author responsible for the plan and have enough reason to receive the file Conditions: We have not made a decision on this matter and a decision will be made after reviewing the request Where to obtain: Endocrine and metabolic disease research center of Loghman -e Hakim hospital ,Shahid Beheshti medical science , Tehran Saeid Kalbasi email:saeidkalbasi@bums.ac.ir How to obtain: The applicant should send her/him request via email and after obtaining permission from all project partners, if the partners agree with her request, the data will be sent to her/him. Comments:
public Seyyed Mahmoud Motalebi
Makhsous Ave
tehran Iran (Islamic Republic of) 1333625445 +98 21 5102 5182 dr_motalebi@yahoo.com Shahid Beheshti University of Medical Sciences scientific saeid kalbasi
yaman
tehran Iran (Islamic Republic of) 1985717443 +98 21 5102 5582 saeidkalbasi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) FBS 100-125 mg/dl Impaired OGTT test 2hours after using 75 grams of oral glucose 18 years 75 years Both pregnant women Chronic alcohol consumption Patients with inflammatory bowel disease Patients with Live Cirrhosis Antibiotic usage during the study Patients with celiac disease Probiotic usage during 30 days before the study Usage of Metformin , anti diabetic agent or herbal medicine Corticosteroids usage R73.01 R73.02 Impaired fasting glucose Impaired glucose tolerance (oral) Prevention Placebo Intervention group: Pre diabetic patients receiving probiotic medicine under trade name Biodiab ,a product of Novagen pharmaceutical company with Tekgene Holding, every 12 hours for 3 months. According to the duration of the study, 180 capsules have been prepared for each person Pre diabetic patients receiving placebo, a maltodextrin composition , under trade name Biodiab ,a product of Novagen pharmaceutical company with Tekgene Holding, every 12 hours for 3 months, placebo in shape size color and packing is as same as probitic. According to the duration of the study, 180 capsules have been prepared for each person Fasting plasma glucose. Timepoint: Before the study and 90 days after intervention. Method of measurement: Photometric method auto analyzer. Blood sugar two hours after a meal. Timepoint: Before the study and 90 days after intervention. Method of measurement: Photometric method auto analyzer. Body weight. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Body weight scale. Systolic blood pressure. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Mercury pressure gauge. Diastolic blood pressure. Timepoint: Mercury pressure gauge. Method of measurement: Before the study and 90 days after the intervention. Body mass index. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Calculator. Total Cholesterol. Timepoint: Before the study and 90 days after the intervention. Method of measurement: colorimetric method with auto-analyzer. Low Density Lipoprotein. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Enzymatic method with auto analyzer. Serum High Density Lipoprotein. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Enzymatic assay with autoanalyser. Serum Triglycerides. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Enzymatic assay with autoanalyser. HbA1c. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Chromatography. High sensitive C-Reactive Protein. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Turbidimetric Method. Novagen Pharmaceutical Company with Tekgen Holding Approved 2022-11-06 Ethics committee of Shahid Beheshti of Medical Sciences Yaman Ave TEHRAN Tehran Iran (Islamic Republic of)