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IRCT20121028011288N17 IRCT 2019-02-28 Tabriz University of Medical Sciences taurine in diabetes The effects of taurine supplementation on serum levels of pentosidine, soluble receptor of advanced glycation end products, methylglyoxal, glycemic, oxidative and nutritional status in patients with type 2 diabetes 2019-02-20 anticipated 46 Complete https://irct.ir/trial/37304 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: the eligible participants will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study, Blinding description: In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the taurine capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company (karenCompany). 3 Type 2 diabetes. Intervention 1: Intervention group: Intervention group: Patients in this group will receive 3 capsules of 1000 milligrams of taurine (product by karen Co. and made in The Iran) for 8 weeks a day. Intervention 2: Control group: Control group: Control group: Patients in this group will receive maltodextrin capsules for 8 weeks which are same size and shape ( product by karen Co. and made in The Iran) and used once a day with lunch. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Accessibility to data is possible 8 months after publication. To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta analysis. Where to obtain: Dr. Mohammad Alizadeh, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences Email: mdalizadeh@tbzmed.ac.ir 0098 9141894102 How to obtain: The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person. Comments:
public Fatemeh Esmaeili
Golgasht street, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3340 8619 fatemehesmaeili@sbmu.ac.ir Tabriz University of Medical Sciences scientific Dr. Mohammad Alizadeh
Golgasht street, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7581 mdalizadeh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with Type 2 Diabetes Patients who use glucose lowering oral medications are well controlled by their blood glucose levels.Body mass index 35-25 kg /m 2 will be included in the study.age range from 20-60 years 30 years 60 years Both Use of multi-vitamin and mineral supplements over the past 3 months.Taking corticosteroids and non-steroidal anti-inflammatory drugs.Taking insulin Patients with polycystic ovary syndrome Patients with chronic diseases such as cardiovascular, renal and hepatic disorders, and hypothyroidism and hyperthyroidism Having certain physiological conditions such as pregnancy and lactation E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Intervention group: Patients in this group will receive 3 capsules of 1000 milligrams of taurine (product by karen Co. and made in The Iran) for 8 weeks a day. Control group: Control group: Control group: Patients in this group will receive maltodextrin capsules for 8 weeks which are same size and shape ( product by karen Co. and made in The Iran) and used once a day with lunch. Pentosidine. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of pentosidin via ELISA kit. Soluble receptor of advanced glycation end products. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of soluble receptor of advanced glycation end products via ELISA kit. Methylglyoxal. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of methylglyoxal via ELISA kit. Assessment of the body composition. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Assess body composition using the body composition analyzer. Physical activity level. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Via IPAQ questionnaire. Assessment of dietary intake. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: 3-day food record. Level of fasting blood sugar (FBS). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of fasting blood sugar (FBS) by enzymatic method. Level of insulin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of insulin by enzymatic method. Level of hemoglobin A1C. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of hemoglobin A1C by enzymatic method. HOMA-IR scores. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of HOMA-IR score using formula. Serum level of total cholesterol (TC). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total cholesterol (TC) level via enzymatic kit. Serum level of triglyceride. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of triglyceride (TG) level via enzymatic kit. Serum level of HDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of HDL level via enzymatic kit. Serum level of LDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of LDL using friedewald equation. Serum level of total antioxidant capacity (TAC). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total antioxidant capacity (TAC) by spectrophotometry. Serum level of malondialdehyde (MDA). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of malondialdehyde (MDA) by spectrophotometry. Serum level of superoxide dismutase (SOD). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of superoxide dismutase (SOD) by spectrophotometry. Tabriz University of Medical Sciences Approved 2018-12-23 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)