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

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00817622

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Antioxidants Diabetes

Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Leptin Vitamin E Tocopherols Tocotrienol

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 ]

Estimated Enrollment:	150
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Vitamin E, Placebo	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
B: Active Comparator EPA, Placebo	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
C: Placebo Comparator Placebo, Placebo	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
D: Active Comparator EPA, Vitamin E	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

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	Recruiting
TEHRAN, Iran, Islamic Republic of
Contact: MAHMOOD - DJALALI, PROFESSOR +989121327189 ext - jalalikh@sina.tums.ac.ir
Contact: SHOKOUH - SARBOLOUKI, Ph.D.STUDENT +989125407311 ext - sarbolouki@razi.tums.ac.ir
Principal Investigator: Mahmood - Djalali, professor

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:	Tehran University of Medical Sciences ( Professor Mahmood Djalali )
Study ID Numbers:	27-4955
Study First Received:	January 3, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00817622 History of Changes
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

diabetes mellitus type 2
EPA
leptin
adiponectin

Study placed in the following topic categories:

Tocopherol acetate
Antioxidants
Metabolic Diseases
Diabetes Mellitus
Tocopherol
Endocrine System Diseases
Trace Elements
Alpha-Tocopherol
Tocopherols

Vitamin E
Tocotrienol
Vitamins
Diabetes Mellitus, Type 2
Tocotrienols
Micronutrients
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Tocopherol acetate
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Protective Agents

Pharmacologic Actions
Alpha-Tocopherol
Tocopherols
Vitamin E
Vitamins
Tocotrienols
Micronutrients
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 02, 2009