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IRCT20170513033941N72 IRCT 2020-06-23 Bagheiat-allah University of Medical Sciences N-acetylcysteine administration in treatment of metabolic syndrome Comparing the effects of N-acetylcysteine and placebo on metabolic profiles and serum adiponectin levels in patients with metabolic syndrome 2020-06-28 anticipated 76 Complete https://irct.ir/trial/44284 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 76 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Endocrinology Clinic of Baqiyatallah Hospital, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups. 3 Metabolic syndrome. Intervention 1: Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), orally, three times a day, for 12 weeks. Intervention 2: Control group: Placebo Tablet (Osve Pharmaceutical Co., Tehran, Iran), three times a day, orally, for 12 weeks. 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr. Yunes Panahi
Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences scientific Dr. Yunes Panahi
Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with metabolic syndrome Individuals aged 25-75 years old 25 years 75 years Both Patients with infectious, malignant and inflammatory diseases Those taking any antioxidant and/or anti-inflammatory supplements within 16 weeks prior to enrollment in the study Hypersensitivity to the study medication Pregnancy or breastfeeding Diabetes mellitus E88.81 Metabolic syndrome Treatment - Drugs Placebo Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), orally, three times a day, for 12 weeks. Control group: Placebo Tablet (Osve Pharmaceutical Co., Tehran, Iran), three times a day, orally, for 12 weeks. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using the Homeostasis Model Assessment (HOMA) formula. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. High-density lipoprotein (HDL). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Low-density lipoprotein (LDL). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. High-sensitivity C-reactive Protein (hs-CRP). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Adiponectin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit. Bagheiat-allah University of Medical Sciences Approved 2020-06-08 Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Molla Sadra Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)