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IRCT20230212057393N2 IRCT 2023-04-18 Mazandaran University of Medical Sciences Evaluating the Effect of Synbiotic Supplements on type 2 Diabetes Evaluating the Effect of Synbiotic Supplements on Hyperglycemia and Insulin Resistance in Patients with Type 2 Diabetes: A Randomized Double-blinded, Clinical Trial 2023-05-05 anticipated 194 Complete https://irct.ir/trial/68899 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of allocating samples into two groups will be based on block classification. The blocking process will be done using random allocation software. This software will generate blocks, and samples will be studied based on the principles of random numbers generated. Based on the above method, the studies will be divided into two synbiotic and control groups, Blinding description: Patients, physicians, and statisticians will not know the intervention distribution. Synbiotic supplements and placebo capsules are entirely similar in terms of appearance, shape, smell, and color and are distinguished from each other only by the A and B codes. Only the data safety and monitoring committee knows its contents and codes. 3 Diabetes mellitus. Intervention 1: 97 Patients are in the synbiotic Supplements( Familact, zisttakhmir Company) Intervention Group. Patients will receive The supplements twice daily for three months. Intervention 2: ninety-seven patients are in the control group. Patients will receive placebo with the same shape, color, and smell as our intervention supplements, twice a day for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no more information.
public Taha Ghasemi
Enghelab Sq, Emam Sajad Hospital, Ramsar City
Ramsar Iran (Islamic Republic of) 4621124141 +98 913 148 3265 mr.taha.ghasemi@gmail.com Mazandaran University of Medical Sciences scientific Fahimeh Naderi Behdani
Enghelab Sq, Emam sajad Hospital, Ramsar, mazandaran
Ramsar Iran (Islamic Republic of) 4695214141 +98 912 705 2419 fahime.naderi90@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All patients in the age group of 30 to 75 years with type 2 diabetes who are diagnosed based on the latest American Diabetes Association(ADA) guidelines. 30 years 75 years Both Pregnant and lactating women Patients receiving hormone therapy, including estrogen and progesterone. Hypothyroidism Patients with kidney disease that have a creatinine level more than two times the upper normal limit. Consumption of any Probiotic, Synbiotic products and Antibiotics in the last three months. Alcohol consumption E14.9 Diabetes mellitus without complications Treatment - Drugs Placebo 97 Patients are in the synbiotic Supplements( Familact, zisttakhmir Company) Intervention Group. Patients will receive The supplements twice daily for three months. ninety-seven patients are in the control group. Patients will receive placebo with the same shape, color, and smell as our intervention supplements, twice a day for 3 months. Hyperglycemia. Timepoint: In the beginning, and after three months. Method of measurement: Test kit for measuring blood sugar. Insulin Resistance. Timepoint: In the beginning, and after three months. Method of measurement: ELISA Insulin Kit. Lipid Profiles. Timepoint: At the Baseline and three months after entering the trial. Method of measurement: Blood test. Body Mass Index. Timepoint: At the Baseline and three months after entering the Trial. Method of measurement: Scale and Tape Measure. Systolic and Diastolic Blood Pressure. Timepoint: At the baseline and three months after entering the Trial. Method of measurement: Mercury Sphygmomanometer. Measure psychological disorder. Timepoint: At the baseline and three months after entering the trial. Method of measurement: The General Health Questionnaire – 28. Appetite assessment. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone. Evaluating the stool condition of patients. Timepoint: At the Baseline and every month after entering the trial. Method of measurement: Question by the research team by phone. Mazandaran University of Medical Sciences Approved 2023-02-19 Ethics committee of Ramsar International Campus Enghelab Sq, Emam Sajad Hospital Ramsar , Mazandaran Ramsar Mazandaran Iran (Islamic Republic of)