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Study aim
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Determination of the effect of alpha lipoic acid supplementation on serum level of lipoprotein-dependent phospholipase A2 and related inflammatory and oxidative stress markers in type 2 diabetic patients
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Design
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A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Clinical trial
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Settings and conduct
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Patients with type 2 diabetes who come to the Diabetes Clinic of Tehran University of Medical Sciences who have inclusion criteria will be included in the study. These patients will be randomized into two intervention and control groups for 2 months. The supplement and placebo are named by a third person in two forms A and B, and the researcher, analyst, and participants will be unaware of this categorization.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: 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%). Non-inclusion criteria: Taking Insulin; History of angina, myocardial infarction, and stroke, as well as other chronic diseases 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
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Intervention groups
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Patients in the intervention group received 1200 mg of alpha-lipoic acid supplement per day, and in the control group received placebo capsules (maltodextrin) for 2 months.
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Main outcome variables
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Lp-PLA2 and its lipoprotein distribution, ICAM-1, VCAM-1, TNF-a, IL-6, 8-isoproprane, and OX-LDL and APO A1