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IRCT20180407039219N1 IRCT 2018-04-27 Tehran University of Medical Sciences Investigating the effect of alpha lipoic acid supplementation on oxidative stress and inflammatory markers in type 2 diabetic patients Investigate the effect of alpha lipoic acid supplementation on serum level of LP-PLA2, it`s distribution between HDL and apo B containing lipoproteins and related oxidative stress and inflammatory markers in type 2 diabetic patients 2018-05-05 anticipated 70 Complete https://irct.ir/trial/30483 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, diabetic patients will be randomly (block randomization) assigned to two intervention and control groups based on sex and menopausal (stratified randomization). We will create four blocks of letters T (treatment) and C (control), such that half the letters of each block T and the other half C (eg TTCC, CTTC, etc.). The blocks will be created and numbered then we will randomly select the blocks needed to reach the sample size and we will put them together. Based on the created pattern, patients will be assigned to two intervention and control groups, Blinding description: The supplements and placebos are similar in terms of shape, odor, taste, and packaging, and are labeled by a third person (from experts in the diabetes clinic) in two forms A and B.Patients, researcher and analyst would not know who was receiving the supplements and who was receiving a placebo. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: The patients in the intervention group will receive 1200 mg daily of alpha-lipoic acid supplements in the form of two 600 mg capsules and they will be asked to take capsules every 12 hours 30 minutes before breakfast and dinner for 2 months. Supplements will be provided by Karen critical pharmaceutical and nutritional supplements company. Intervention 2: Control group: The patients in the control group will receive two placebo capsules (maltodextrin) and they will be asked to take capsules every 12 hours 30 minutes before breakfast and dinner for 2 months.Placebo capsules will be provided by Karen critical pharmaceutical and nutritional supplements company. 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 After the study, depending on the condition the decision will be made
public Dr. Saeed Hosseini
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No 44, Hojjatdoust alley, Naderi St., Keshavarz blv.
Tehran Iran (Islamic Republic of) - +98 21 8895 5569 Hosseinis@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Saeed Hosseini
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No 44, Hojjatdoust alley, Naderi St., Keshavarz blv.
Tehran Iran (Islamic Republic of) - +98 21 8895 5569 Hosseinis@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate Age between 40-60 years old Body mass index (BMI) between 18.5 to 29.9 At least 2 years of diagnosed type 2 diabetes Controlled diabetes (HbA1C < 7%) 40 years 60 years Both Taking insulin History of angina, myocardial infarction, and stroke, as well as other chronic diseases including liver disease, gastrointestinal disease, kidney disease, malignant disease, thyroid disease and other chronic and infectious diseases in the past year Tobacco and alcohol consumption in the last three months Changes in treatment protocols in the last three months Taking any medicine other than metformin, glibenclamide, statin drugs, ACEI, ARB and doses less than 80 mg aspirin Regular use of herbal Supplements containing antioxidants and omega-3 in the last three months (at least once a week) Pregnancy and lactation E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: The patients in the intervention group will receive 1200 mg daily of alpha-lipoic acid supplements in the form of two 600 mg capsules and they will be asked to take capsules every 12 hours 30 minutes before breakfast and dinner for 2 months. Supplements will be provided by Karen critical pharmaceutical and nutritional supplements company. Control group: The patients in the control group will receive two placebo capsules (maltodextrin) and they will be asked to take capsules every 12 hours 30 minutes before breakfast and dinner for 2 months.Placebo capsules will be provided by Karen critical pharmaceutical and nutritional supplements company. Lipoprotein-associated phospholipase A2 (Lp-PLA2). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. Lipoprotein-associated phospholipase A2 distribution among lipoproteins. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. ICAM-1. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. VCAM-1. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. TNF-a. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. Interleukin 6. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. 8-Isoprostane. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. OX-LDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. Apolipoprotein A1. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. Glucose. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Photometric assay. Insuline. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay. Total cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic assay. HDL Cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic assay. LDL Cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Friedewald formula. Triglyceride. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic assay. Tehran University of Medical Sciences Approved 2018-02-20 Ethics committee of Tehran University of Medical Sciences Qods st., Keshavarz blv. Tehran Tehran Iran (Islamic Republic of)