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

Tehran University of Medical Sciences

Status: Completed

Conditions: Diabetes Mellitus Type II

Treatments: Dietary Supplement: EPA Supplement; Dietary Supplement: EPA Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03258840

15202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

EPA placebo

Placebo Comparator group

Description:

EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks

Treatment:

Dietary Supplement: EPA Placebo

EPA supplement

Active Comparator group

Description:

EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.

Treatment:

Dietary Supplement: EPA Supplement