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IRCT20190801044405N1 IRCT 2020-10-25 Vice chancellor for research, Mashhad University of Medical Sciences The effect of probiotic on serum adiponectin level in pre-diabetic patients The effect of probiotic on serum adiponectin level in pre-diabetic patients 2021-01-14 anticipated 50 Complete https://irct.ir/trial/41383 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Initially, a physical examination including height, weight, BMI, and systolic and diastolic blood pressure are performed in patients. Patients are referred to the laboratory for measurement of Insulin-FBS-LDL-HDL-TG-HBA1C. Serum levels of adiponectin are also measured in the following tests. Patients are then randomly divided into two groups, one group receiving probiotic pills more than 109 CFU equivalent to 500 mg capsules daily and the other group receiving placebo. Also, given that BMI is effective on adiponectin levels, patients are randomized based on their BMI, Blinding description: We used odd numbers for the main drug and even numbers for placebo, patients pick a card and based on number of their card our assistant give them a pack of placebo or drug. 3 diabetes. Intervention 1: Intervention group:500mg capsules of Lactocare probiotic for 3 month, 1 capsule daily. Intervention 2: Control group: 500mg placebo capsules for 3 month, 1 capsule daily. 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 Mina Akbari Rad
Khorasan Razavi, Mashhad, Ahmadabad St., Ghaem Hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2370 akbariradm@mums.ac.ir Mashhad University of Medical Sciences scientific Mina Akbari Arad
Khorasan Razavi, Mashhad, Ahmadabad St., Ghaem Hospital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2370 akbariradm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All prediabetic patients aged 30 to 65 years 30 years 65 years Both Patients with previously diagnosed diabetes treated with hypoglycemic drugs such as metformin and such Patients with a prior diagnosis of pre-diabetes who are under medication treatment R73.09 Other abnormal glucose Prevention Placebo Intervention group:500mg capsules of Lactocare probiotic for 3 month, 1 capsule daily Control group: 500mg placebo capsules for 3 month, 1 capsule daily Serum adiponectin levels. Timepoint: Before intervention and after 3 months of medication. Method of measurement: blood test. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2019-04-09 Ethics committee of Mashhad University of Medical Sciences Azadi Square, east door of Ferdowsi University campus, Faculty of Medicine Mashhad Razavi Khorasan Iran (Islamic Republic of)