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

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: Completed
• Conditions: Diabetes Mellitus Type II
• Intervention / Treatment: Dietary supplement: EPA Placebo; Dietary supplement: EPA Supplement

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: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
HbA1c	Hemoglobin A1c (HbA1c) measurement by related kits according their protocols	Change from Baseline at 8 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PON2 gene expression	measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR	Baseline, 8 weeks after the intervention
Systolic blood pressure	Systolic blood pressure changes measurement by manometer	Change frome baseline at 8 weeks
Diastolic blood pressure	Diastolic blood pressure changes measurement by manometer	Change frome baseline at 8 weeks
serum paraoxonase-1(PON-1) activity	serum paraoxonase-1(PON-1) activity by kit according related protocol	Baseline, 8 weeks after the intervention
PON1/HDL-c Ratio	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	measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol	Baseline, 8 weeks after the intervention
HDL-c	high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
FBS	Fasting blood sugar (FBS) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
HDL2-c	high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
HDL3-c	high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Serum apo B	Serum apo-protein B measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Serum apo A-I	Serum apo-protein A-I measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
apo B/apo A-I Ratio	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	measurement of serum levels of methionine by related kit according its protocol	Baseline, 8 weeks after the intervention
Serum malondialdehyde (MDA)	measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol	Baseline, 8 weeks after the intervention
Serum homocysteine (Hcy)	measurement of serum levels of homocysteine (Hcy) by related kit according its protocol	Baseline, 8 weeks after the intervention
Serum sE-Selectin	measurement of serum levels of soluble E-Selectin by related kit according its protocol	Baseline, 8 weeks after the intervention
sVCAM-1	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	measurement of serum levels of cysteine by related kit according its protocol	Baseline, 8 weeks after the intervention
Serum Lpa	measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol	Baseline, 8 weeks after the intervention

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: 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

General Publications

• Golzari MH, Javanbakht MH, Ghaedi E, Mohammadi H, Djalali M. Effect of Eicosapentaenoic Acid Supplementation on Paraoxonase 2 Gene Expression in Patients with Type 2 Diabetes Mellitus: a Randomized Double-blind Clinical Trial. Clin Nutr Res. 2019 Jan 28;8(1):17-27. doi: 10.7762/cnr.2019.8.1.17. eCollection 2019 Jan.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 16, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Type 2 diabetes; EPA; Paraoxonase 1; Paraoxonase 2
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
• Other Study ID Numbers: 15202