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NCT00817622

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

NCT ID: NCT00817622

Last Updated: 2009-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Diabetes Mellitus

Keywords

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diabetes mellitus type 2 EPA leptin adiponectin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

EPA, Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

EPA, Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type PLACEBO_COMPARATOR

EPA, Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

EPA, Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Plus EPA

Eligibility Criteria

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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,

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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Mahmood Djalali, Professor

Role: STUDY_CHAIR

Tehran University of Medical Sciences, school of Public Health

Shokooh Sarbolouki, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences, School of Public Health

Ahmad Reza - Dorosti, Ph.D.

Role: STUDY_CHAIR

Tehran University of Medical Sciences,School of Public Health

Locations

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Tehran University Of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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Sarbolouki Sh, Djalali M, Dorosty A, Djazayery S, Eshraghian M, Ebadi S, Hashemi S. Effects of EPA and Vitamin E on Serum Enzymatic Antioxidants and Peroxidation Indices in Patients with Type II Diabetes Mellitus. Iran J Public Health. 2010;39(3):82-91. Epub 2010 Sep 30.

Reference Type DERIVED

PMID: 23113026 (View on PubMed)

Other Identifiers

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27-4955

Identifier Type: -

Identifier Source: org_study_id