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Completed

NCT Number: NCT00817622

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

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

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tehran University Of Medical Sciences

Tehran, Tehran Province, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

EPA, Vitamin E

Dietary Supplement

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

Other names: Plus EPA

Primary outcomes

  1. Changes in leptin and adiponectin after 12 Weeks

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study 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

Acronym: EPA

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Nov 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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