EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus

August 22, 2017 updated by: Tehran University of Medical Sciences

The Effect of EPA on the Serum Activities of Paraoxonase 1, Homocystein, Thiolactonase and Some Indicators of Vascular Inflammation and PON2 Gene Expression in PBMC Ofthe Patients With Type II Diabetes

The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase, and serum levels of some indicators of vascular inflammation, and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study is to determining of the effects of Eicosapentaenoic acid (EPA) supplementation on serum activities of Paraoxonase-1 and Homocystein thiolactonase and several indicators of vascular inflammation and the gene expression of PON2 in the peripheral blood mononuclear cell (PBMC) in the patients with type II diabetes mellitus. In this randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women aged 35-50 years with type 2 diabetes are enrolled in the study from the Iranian Diabetes Association. After signing informed consent, all individuals complete a general information form. a 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. Two groups will be classified (blocked) based on sex. The supplement group, will receive 2 g/day EPA for 8 weeks and the placebo group will also receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1471613151
        • Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Willingness to collaborate in the study
  • aged 35-50 years
  • having a history of at least 1 year of type 2 diabetes mellitus before the participation in the study based on FBS ≥126 mg/dl or 2hPG ≥200 mg/dl (2-hour plasma glucose),
  • 25≤BMI<30 kg/m2

Exclusion criteria:

  • pregnant and breastfeeding women
  • using insulin, alcohol consumption, smoking and other drugs
  • taking drugs (lipid-lowering, β-blockers, diuretics, estrogens, progesterones, vitamin supplements and ω-3 fatty acid supplements
  • followers of the special diet
  • history of diabetic retinopathy or diabetic nephropathy
  • type 1 diabetes mellitus and other disorders
  • any need to take insulin, change in the dose (s) and type of medication or physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: EPA placebo
EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks
Dietary supplement: EPA Placebo
EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.
Active Comparator: EPA supplement
EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.
Dietary supplement: EPA Supplement
EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.
Other Names:
  • Eicosapentaenoic acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Change from Baseline at 8 weeks after the intervention
Hemoglobin A1c (HbA1c) measurement by related kits according their protocols
Change from Baseline at 8 weeks after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PON2 gene expression
Time Frame: Baseline, 8 weeks after the intervention
measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR
Baseline, 8 weeks after the intervention
Systolic blood pressure
Time Frame: Change frome baseline at 8 weeks
Systolic blood pressure changes measurement by manometer
Change frome baseline at 8 weeks
Diastolic blood pressure
Time Frame: Change frome baseline at 8 weeks
Diastolic blood pressure changes measurement by manometer
Change frome baseline at 8 weeks
serum paraoxonase-1(PON-1) activity
Time Frame: Baseline, 8 weeks after the intervention
serum paraoxonase-1(PON-1) activity by kit according related protocol
Baseline, 8 weeks after the intervention
PON1/HDL-c Ratio
Time Frame: Baseline, 8 weeks after the intervention
calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols
Baseline, 8 weeks after the intervention
serum paraoxonase lactonase (PON-HCTLase) activity
Time Frame: Baseline, 8 weeks after the intervention
measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol
Baseline, 8 weeks after the intervention
HDL-c
Time Frame: Baseline, 8 weeks after the intervention
high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols
Baseline, 8 weeks after the intervention
FBS
Time Frame: Baseline, 8 weeks after the intervention
Fasting blood sugar (FBS) measurement by related kits according their protocols
Baseline, 8 weeks after the intervention
HDL2-c
Time Frame: Baseline, 8 weeks after the intervention
high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols
Baseline, 8 weeks after the intervention
HDL3-c
Time Frame: Baseline, 8 weeks after the intervention
high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols
Baseline, 8 weeks after the intervention
Serum apo B
Time Frame: Baseline, 8 weeks after the intervention
Serum apo-protein B measurement by related kits according their protocols
Baseline, 8 weeks after the intervention
Serum apo A-I
Time Frame: Baseline, 8 weeks after the intervention
Serum apo-protein A-I measurement by related kits according their protocols
Baseline, 8 weeks after the intervention
apo B/apo A-I Ratio
Time Frame: Baseline, 8 weeks after the intervention
calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols
Baseline, 8 weeks after the intervention
Serum methionine
Time Frame: Baseline, 8 weeks after the intervention
measurement of serum levels of methionine by related kit according its protocol
Baseline, 8 weeks after the intervention
Serum malondialdehyde (MDA)
Time Frame: Baseline, 8 weeks after the intervention
measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol
Baseline, 8 weeks after the intervention
Serum homocysteine (Hcy)
Time Frame: Baseline, 8 weeks after the intervention
measurement of serum levels of homocysteine (Hcy) by related kit according its protocol
Baseline, 8 weeks after the intervention
Serum sE-Selectin
Time Frame: Baseline, 8 weeks after the intervention
measurement of serum levels of soluble E-Selectin by related kit according its protocol
Baseline, 8 weeks after the intervention
sVCAM-1
Time Frame: Baseline, 8 weeks after the intervention
measurement of serum levels of soluble Vascular cell adhesion molecule-1 (VCAM-1) by related kit according its protocol
Baseline, 8 weeks after the intervention
Serum cysteine
Time Frame: Baseline, 8 weeks after the intervention
measurement of serum levels of cysteine by related kit according its protocol
Baseline, 8 weeks after the intervention
Serum Lpa
Time Frame: Baseline, 8 weeks after the intervention
measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol
Baseline, 8 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tehran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohammad Hassan Golzari, Ph.D, Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
  • Study Chair: Mahmoud Djallali, Ph.D, Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
  • Study Director: Saeed Hosseini, MD,Ph.D, Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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