Effects of EPA and Vitamin E on Leptin, Adiponectin and Enzymatic Antioxidants in Type 2 DM
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00817622
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic Acid)alone and with VitE in diabetic patients.
- Detailed Description
Randomized, double-blind, placebo-controlled, parallel-group study design After a 12weeks, subjects with type II DM will be randomized to receive either 2000 mg pearl EPA per day plus a double-blinded matching placebo (1 corn oil pearls per day) for 12 weeks OR 400 mg VitE pearl plus double-blinded per day plus a double-blinded matching placebo (4 corn oil pearls per day) for 12 weeks OR 2000 mg pearl EPA per day plus a double-blinded matching 400 mg VitE pearl OR placebo(4corn oil pearls per day plus 1 corn oil pearls per day )for 12 weeks.The total dose of EPA pearl will be 2000 mg per day (with the EPA or matching placebo corn oil doses remaining at 4 pearls per day) and The total dose of VitE pearl will be 400 mg per day (with the VitE or matching placebo corn oil doses remaining at 1 pearls per day).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- DM Type II.
- Antidiabetic drug therapy which cannot be stopped.
- History of DM about 2-15 year.
- Age between 30-55 year.
- No History of circulatory, thyroid, pulmonary, liver, kidney, cancer.
- DM Type I.
- Nephropathy.
- Retinopathy.
- Cancer.
- Thyroid disease.
- Renal failure.
- pulmonary disease
- MI.
- CHD.
- Liver disease,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Changes in leptin and adiponectin after 12 Weeks 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tehran University Of Medical Sciences
🇮🇷Tehran, Iran, Islamic Republic of
Tehran University Of Medical Sciences🇮🇷Tehran, Iran, Islamic Republic of