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

Diabetes Mellitus Type II Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258840
• Other study ID #: 15202
• Status: Completed
• Phase: N/A
• First received: July 16, 2017
• Last updated: August 22, 2017
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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, ß-blockers, diuretics, estrogens, progesterones, vitamin supplements and ?-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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2
• Inflammation

Intervention

Dietary Supplement:
• EPA Supplement
EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.
• EPA Placebo
EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Hemoglobin A1c (HbA1c) measurement by related kits according their protocols	Change from Baseline at 8 weeks after the intervention
Secondary	PON2 gene expression	measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR	Baseline, 8 weeks after the intervention
Secondary	Systolic blood pressure	Systolic blood pressure changes measurement by manometer	Change frome baseline at 8 weeks
Secondary	Diastolic blood pressure	Diastolic blood pressure changes measurement by manometer	Change frome baseline at 8 weeks
Secondary	serum paraoxonase-1(PON-1) activity	serum paraoxonase-1(PON-1) activity by kit according related protocol	Baseline, 8 weeks after the intervention
Secondary	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
Secondary	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
Secondary	HDL-c	high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Secondary	FBS	Fasting blood sugar (FBS) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Secondary	HDL2-c	high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Secondary	HDL3-c	high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Secondary	Serum apo B	Serum apo-protein B measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Secondary	Serum apo A-I	Serum apo-protein A-I measurement by related kits according their protocols	Baseline, 8 weeks after the intervention
Secondary	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
Secondary	Serum methionine	measurement of serum levels of methionine by related kit according its protocol	Baseline, 8 weeks after the intervention
Secondary	Serum malondialdehyde (MDA)	measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol	Baseline, 8 weeks after the intervention
Secondary	Serum homocysteine (Hcy)	measurement of serum levels of homocysteine (Hcy) by related kit according its protocol	Baseline, 8 weeks after the intervention
Secondary	Serum sE-Selectin	measurement of serum levels of soluble E-Selectin by related kit according its protocol	Baseline, 8 weeks after the intervention
Secondary	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
Secondary	Serum cysteine	measurement of serum levels of cysteine by related kit according its protocol	Baseline, 8 weeks after the intervention
Secondary	Serum Lpa	measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol	Baseline, 8 weeks after the intervention