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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Dietary Supplement: EPA, Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT00817622

27-4955

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic Acid)alone and with VitE in diabetic patients.

Full 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).

Enrollment: 129 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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129 participants in 4 patient groups, including a placebo group

A

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: EPA, Vitamin E

B

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: EPA, Vitamin E

C

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: EPA, Vitamin E

D

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: EPA, Vitamin E