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

Primary Purpose

Diabetes Mellitus Type II

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
EPA Supplement
EPA Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type II focused on measuring EPA, Paraoxonase 1, Paraoxonase 2, Type 2 diabetes

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

EPA placebo

EPA supplement

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2017
Last Updated
August 22, 2017
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03258840
Brief Title
EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type II
Keywords
EPA, Paraoxonase 1, Paraoxonase 2, Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPA placebo
Arm Type
Placebo Comparator
Arm Description
EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks
Arm Title
EPA supplement
Arm Type
Active Comparator
Arm Description
EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA Supplement
Other Intervention Name(s)
Eicosapentaenoic acid
Intervention Description
EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA Placebo
Intervention Description
EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.
Primary Outcome Measure Information:
Title
HbA1c
Description
Hemoglobin A1c (HbA1c) measurement by related kits according their protocols
Time Frame
Change from Baseline at 8 weeks after the intervention
Secondary Outcome Measure Information:
Title
PON2 gene expression
Description
measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR
Time Frame
Baseline, 8 weeks after the intervention
Title
Systolic blood pressure
Description
Systolic blood pressure changes measurement by manometer
Time Frame
Change frome baseline at 8 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure changes measurement by manometer
Time Frame
Change frome baseline at 8 weeks
Title
serum paraoxonase-1(PON-1) activity
Description
serum paraoxonase-1(PON-1) activity by kit according related protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
PON1/HDL-c Ratio
Description
calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
serum paraoxonase lactonase (PON-HCTLase) activity
Description
measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
HDL-c
Description
high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
FBS
Description
Fasting blood sugar (FBS) measurement by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
HDL2-c
Description
high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
HDL3-c
Description
high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum apo B
Description
Serum apo-protein B measurement by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum apo A-I
Description
Serum apo-protein A-I measurement by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
apo B/apo A-I Ratio
Description
calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum methionine
Description
measurement of serum levels of methionine by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum malondialdehyde (MDA)
Description
measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum homocysteine (Hcy)
Description
measurement of serum levels of homocysteine (Hcy) by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum sE-Selectin
Description
measurement of serum levels of soluble E-Selectin by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
sVCAM-1
Description
measurement of serum levels of soluble Vascular cell adhesion molecule-1 (VCAM-1) by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum cysteine
Description
measurement of serum levels of cysteine by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention
Title
Serum Lpa
Description
measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol
Time Frame
Baseline, 8 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Hassan Golzari, Ph.D
Organizational Affiliation
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahmoud Djallali, Ph.D
Organizational Affiliation
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Saeed Hosseini, MD,Ph.D
Organizational Affiliation
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
Official's Role
Study Director
Facility Information:
Facility Name
Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition
City
Tehran
ZIP/Postal Code
1471613151
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30746344
Citation
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.
Results Reference
derived

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

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