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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03258840

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type II	Dietary Supplement: EPA Supplement Dietary Supplement: EPA Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

HbA1c [Change from Baseline at 8 weeks after the intervention]
Hemoglobin A1c (HbA1c) measurement by related kits according their protocols

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition	Tehran		Iran, Islamic Republic of	1471613151

Sponsors and Collaborators

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)