]>
IRCT20170918036256N1 IRCT 2017-12-15 Zanjan University of Medical Sciences Effect of Atorvastation in combination with vitamin E on treatment of hyperlipidemia Comparison of the effect of Atorvastatin alone & in combination with vitamin E on peroxisome proliferator-activated receptor-gamma gene expression and insulin resistance indices in type 2 diabetic patients with hyperlipidemia 2017-07-02 anticipated 30 Complete https://irct.ir/trial/27159 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. By a flip of a coin, the first patient will be considered at the intervention and the second one will be as control group, Blinding description: After collecting the consent form to participate in the study, participants recieved drugs with the same shape and number. Clinical care person and researcher were blinded through coding at the randome allocation. N/A Type 2 diabetes mellitus. Intervention 1: Atorvastatin 20 mg (Jalinus Co, Iran) and vitamin E 400 IU (Zahravi Co, Iran), daily after meal, for 12 weeks. Intervention 2: Atorvastatin 20 mg (Jalinus Co, Iran) and placebo (containing corn oil, Zahravi Co, Iran), daily after meal, for 12 weeks. Yes - There is a plan to make this available What will be shared: Results of data analysis will be reported. When: access starts 6 month after publishing the results To whom: Researchers at the universities Conditions: Useless Where to obtain: E-mail tabaei.banafsheh@zums.ac.ir How to obtain: Electronic mail Comments:
public Banafsheh Sadat Tabaei Jabali
12th St, Mahdavi Blv, Zanjan University of Medical Sciences
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3344 0300 tabaei.banafsheh@yahoomail.com Zanjan University of Medical Sciences scientific Ali Mellati
12th St, Mahdavi Blv, Zanjan University of Medical Sciences
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3344 0300 mellati@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: atorvastatin intake at the dose of 20 mg/day; fasting blood sugar more than 126 mg/dl & two hour plasma glucose more than 200 mg/dl in two regular tests; body mass index between 25 to 35 kg/m2; age of 18 to 65 years; glycated hemoglobin of 7 to 9 percent; Iranian ethnicity Exclusion criteria: bogy mass index lower than 25 kg/m2; pregnant and lactating women or whom decide to pregnancy; chronic diseases such as inflammatory diseases, heart, liver, renal failure, cancer, acute myocardial infarction, type 1 diabetes, stroke & serious injuries; drugs of tiazolidinediones family such as pioglitazone; intake of multivitamin or antioxidant supplements at least for 3 month ago; use of alcohol or cigarette; malabsorptive diseases such as celiac & steatorrhea; liver genetic diseases such as copper or iron storage; athletes; people on special diets 18 years 65 years Female E11 Non-insulin-dependent diabetes mellitus Treatment - Drugs Placebo Atorvastatin 20 mg (Jalinus Co, Iran) and vitamin E 400 IU (Zahravi Co, Iran), daily after meal, for 12 weeks Atorvastatin 20 mg (Jalinus Co, Iran) and placebo (containing corn oil, Zahravi Co, Iran), daily after meal, for 12 weeks Peroxisome proliferator-activated receptor-gamma gene expression. Timepoint: At the beginning and after 12 weeks. Method of measurement: Polymerase chain reaction. Insulin resistance indice. Timepoint: At the beginning and after 12 weeks. Method of measurement: HOMA-IR formula. Triglyceride. Timepoint: At the beginning and after 12 weeks. Method of measurement: Autoanalyzer. Total cholesterol. Timepoint: At the beginning and after 12 weeks. Method of measurement: Autoanalyzer. Low density lipoprotein cholesterol. Timepoint: At the beginning and after 12 weeks. Method of measurement: Autoanalyzer. High density lipoprotein cholesterol. Timepoint: At the beginning and after 12 weeks. Method of measurement: Autoanalyzer. Fasting glucose. Timepoint: At the beginning and after 12 weeks. Method of measurement: Autoanalyzer. Two-hour plasma glucose. Timepoint: At the beginning and after 12 weeks. Method of measurement: Autoanalyzer. Insulin resistane. Timepoint: At the beginning and after 12 weeks. Method of measurement: Fasting insulin *fasting glucose/ 405. Fasting insulin. Timepoint: At the beginning and after 12 weeks. Method of measurement: ELISA kit. Weight reduction. Timepoint: At the beginning and after 12 weeks. Method of measurement: Scale. Waist circumference. Timepoint: At the beginning and after 12 weeks. Method of measurement: Meter. Glycosylated hemoglobin. Timepoint: At the beginning and after 12 weeks. Method of measurement: Autoanalyzer. Zanjan University of Medical Sciences Approved 2017-05-22 Zanjan University of Medical Sciences 12th street., Mahdavi Blvd., Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)