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
Determination the effect of atorvastatin alone and in combination with vitamin E on Peroxisome Proliferator-Activated Receptor-gamma gene expression in type 2 diabetic patients with hyperlipidemia
Determination the effect of atorvastatin alone and in combination with vitamin E on insulin resistance indice (HOMA-IR) in type 2 diabetic patients with hyperlipidemia
Determination the effect of atorvastatin alone and in combination with vitamin E on fasting serum insulin in type 2 diabetic patients with hyperlipidemia
Determination the effect of atorvastatin alone and in combination with vitamin E on fasting blood glucose in type 2 diabetic patients with hyperlipidemia
Determination the effect of atorvastatin alone and in combination with vitamin E on blood lipid profile (triglyceride, total cholesterol, LDL and HDL) in type 2 diabetic patients with hyperlipidemia
Determination the effect of atorvastatin alone and in combination with vitamin E on weight loss in type 2 diabetic patients with hyperlipidemia
Determination the effect of atorvastatin alone and in combination with vitamin E on waist circumference in type 2 diabetic patients with hyperlipidemia
Design
In this research, 30 eligible type 2 diabetic patients with hyperlipidemia referring to clinics of Vali-e-Asr Hospital were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This study is a double-blinded (researcher/patient) randomized clinical trial. the aim of the present study is finding the suitable treatment method with lower complications for type 2 diabetic patients with hyperlipidemia. Thirty women with type 2 diabetes which have hyperlipidemia and HbA1c= 7-9% who were attending to the clinics of Vali-e-Asr Hospital will be enrolled. Patients were randomely devided to two equal groups. The first group: recieve atorvastatin 20 mg plus placebo and the second group recieve 20 mg atorvastatin plus 400 IU vitamin E supplement daily for 12 weeks. At the end, results will be compared between the two groups, as well as in each group from baseline up to the end.
Participants/Inclusion and exclusion criteria
Inclusion critera: women with type 2 diabetes who recieve 20 mg per day atorvastatin to control blood lipid; body mass index between 25 to 35 kg/m2; age of 18 to 65 years; glycated hemoglobin of 7 to 9 percent; Exclusion criteria: body mass index lower than 25 kg/m2; pregnant and lactating women; patients with chronic diseases; intake of tiazolidinediones family; intake of supplements at least for 3 month ago; use of alcohol or cigarette; malabsorptive diseases; people on special diets
Intervention groups
Control group: 20 mg atorvastatin plus placebo, daily
Intervention group: 20 mg atorvastatin plus 400 IU vitamin E supplement, daily
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
Public title
Effect of Atorvastation in combination with vitamin E on treatment of hyperlipidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
12th street., Mahdavi Blvd., Zanjan University of Medical Sciences