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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00817622

Collaborator

(none)

129

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Dietary Supplement: EPA, Vitamin E	Phase 4

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: Plus EPA

Outcome Measures

Primary Outcome Measures

Changes in leptin and adiponectin after 12 Weeks [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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