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

Tehran University of Medical Sciences36 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus Type II

Interventions

EPA SupplementDIETARY_SUPPLEMENT

EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.

EPA PlaceboDIETARY_SUPPLEMENT

EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition

Tehran, Iran

Outcomes

Primary Outcomes

HbA1c

Hemoglobin A1c (HbA1c) measurement by related kits according their protocols

Time frame: Change from Baseline at 8 weeks after the intervention

Secondary Outcomes

PON2 gene expression

measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR

Time frame: Baseline, 8 weeks after the intervention

Systolic blood pressure

Systolic blood pressure changes measurement by manometer

Time frame: Change frome baseline at 8 weeks

Diastolic blood pressure

Diastolic blood pressure changes measurement by manometer

Time frame: Change frome baseline at 8 weeks

serum paraoxonase-1(PON-1) activity

serum paraoxonase-1(PON-1) activity by kit according related protocol

Time frame: 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

Time frame: 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

Time frame: Baseline, 8 weeks after the intervention

HDL-c

high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols

Data from ClinicalTrials.gov

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