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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170918036256N1

Enrollment

Registered

2017-12-15

Start date

2017-07-02

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus. Non-insulin-dependent diabetes mellitus

Interventions

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 (contai

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

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBanafsheh Sadat Tabaei Jabali

Zanjan University of Medical Sciences

tabaei.banafsheh@yahoomail.com+98 24 3344 0300

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026