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

Diabetes Mellitus Clinical Trial

— EPA  

Official title:

Effects of EPA Alone and Combined With Vitamin E on Blood Leptin, Adiponectin and Enzymatic Antioxidants Levels in Type II Diabetic Patients; A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817622
• Other study ID #: 27-4955
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2009
• Last updated: November 17, 2009
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Dietary Supplement:
• EPA, Vitamin E
EPA pearls, 500 mg QID for 12 Weeks (2000 mg per day) Vitamin E pearls, 400 mg per day for 12 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University Of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in leptin and adiponectin after 12 Weeks		12 weeks	Yes