Trial record 13 of 91 for:    "ACDC"

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
  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:


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 April 15, 2014