Effects of EPA and Vitamin E on Leptin, Adiponectin and Enzymatic Antioxidants in Type 2 DM

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: EPA, Vitamin E

• 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).

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-01-03
• Study First Submitted QC: 2009-01-03
• Study First Posted: 2009-01-06
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-17
• Last Update Posted: 2009-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• 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.

Exclusion Criteria

• DM Type I.
• Nephropathy.
• Retinopathy.
• Cancer.
• Thyroid disease.
• Renal failure.
• pulmonary disease
• MI.
• CHD.
• Liver disease,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
B	EPA, Vitamin E	EPA, Placebo : EPA pearls,500 mg QID for 12 Weeks (2000 mg per day),From MINAMINUTRITION Company(Belgium)+ Placebo pearl ,corn oil 400 mg per day for 12 weeks
C	EPA, Vitamin E	Placebo ,Vitamin E : Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day)+ Vitamin E pearls, 400 mg from DANA Company(IRAN) per day for 12 weeks
D	EPA, Vitamin E	EPA, Vitamin E : EPA pearls,500 mg QID From MINAMINUTRITION Company(Belgium) for 12 Weeks (2000 mg EPA per day)+ Vitamin E pearls, 400 mg from DANA Company ( IRAN) per day for 12 weeks
A	EPA, Vitamin E	Placebo, Placebo : Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day) Placebo pearl + corn oil 400 mg per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in leptin and adiponectin after 12 Weeks	12 weeks

Trial Locations

Locations (1)

Tehran University Of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of