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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00817622
First received: January 3, 2009
Last updated: November 17, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
 Dietary Supplement: EPA, Vitamin E
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Changes in leptin and adiponectin after 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A

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

 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
Other Name: Plus EPA
Active Comparator: B

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

 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
Other Name: Plus EPA
Placebo Comparator: C

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

 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
Other Name: Plus EPA
Active Comparator: D

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

 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
Other Name: Plus EPA

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).

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817622

Locations
Iran, Islamic Republic of
Tehran University Of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Mahmood Djalali, Professor Tehran University of Medical Sciences, school of Public Health
Principal Investigator: Shokooh Sarbolouki, PhD Student Tehran University of Medical Sciences, School of Public Health
Study Chair: Ahmad Reza - Dorosti, Ph.D. Tehran University of Medical Sciences,School of Public Health
  More Information

No publications provided

Responsible Party: Professor Mahmood Djalali, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00817622     History of Changes
Other Study ID Numbers: 27-4955
Study First Received: January 3, 2009
Last Updated: November 17, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
diabetes mellitus type 2
EPA
leptin
adiponectin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antioxidants
Vitamin E
Alpha-Tocopherol
Tocopherols
 Tocotrienols
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013