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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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ClinicalTrials.gov Identifier: NCT03258840
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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 Name: Eicosapentaenoic acid




Primary Outcome Measures :
  1. HbA1c [ Time Frame: Change from Baseline at 8 weeks after the intervention ]
    Hemoglobin A1c (HbA1c) measurement by related kits according their protocols


Secondary Outcome Measures :
  1. PON2 gene expression [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of paraoxonase-2(PON-2) gene expression using quantitative Real-time PCR

  2. Systolic blood pressure [ Time Frame: Change frome baseline at 8 weeks ]
    Systolic blood pressure changes measurement by manometer

  3. Diastolic blood pressure [ Time Frame: Change frome baseline at 8 weeks ]
    Diastolic blood pressure changes measurement by manometer

  4. serum paraoxonase-1(PON-1) activity [ Time Frame: Baseline, 8 weeks after the intervention ]
    serum paraoxonase-1(PON-1) activity by kit according related protocol

  5. PON1/HDL-c Ratio [ Time Frame: Baseline, 8 weeks after the intervention ]
    calculating the ratio after measurement of PON1 and HDL-c by related kits according their protocols

  6. serum paraoxonase lactonase (PON-HCTLase) activity [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of paraoxonase lactonase (PON-HCTLase) activity by related kit according its protocol

  7. HDL-c [ Time Frame: Baseline, 8 weeks after the intervention ]
    high density lipoprotein- cholesterol (HDL-c) measurement by related kits according their protocols

  8. FBS [ Time Frame: Baseline, 8 weeks after the intervention ]
    Fasting blood sugar (FBS) measurement by related kits according their protocols

  9. HDL2-c [ Time Frame: Baseline, 8 weeks after the intervention ]
    high density lipoprotein 2- cholesterol (HDL2-c) measurement by related kits according their protocols

  10. HDL3-c [ Time Frame: Baseline, 8 weeks after the intervention ]
    high density lipoprotein 3- cholesterol (HDL3-c) measurement by related kits according their protocols

  11. Serum apo B [ Time Frame: Baseline, 8 weeks after the intervention ]
    Serum apo-protein B measurement by related kits according their protocols

  12. Serum apo A-I [ Time Frame: Baseline, 8 weeks after the intervention ]
    Serum apo-protein A-I measurement by related kits according their protocols

  13. apo B/apo A-I Ratio [ Time Frame: Baseline, 8 weeks after the intervention ]
    calculating the ratio after measurement of apo B and apo A-1 by related kits according their protocols

  14. Serum methionine [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of serum levels of methionine by related kit according its protocol

  15. Serum malondialdehyde (MDA) [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of serum levels of malondialdehyde (MDA)by related kit according its protocol

  16. Serum homocysteine (Hcy) [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of serum levels of homocysteine (Hcy) by related kit according its protocol

  17. Serum sE-Selectin [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of serum levels of soluble E-Selectin by related kit according its protocol

  18. sVCAM-1 [ Time Frame: 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

  19. Serum cysteine [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of serum levels of cysteine by related kit according its protocol

  20. Serum Lpa [ Time Frame: Baseline, 8 weeks after the intervention ]
    measurement of serum levels of lipoprotein-a (Lpa)by related kit according its protocol



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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258840


Locations
Iran, Islamic Republic of
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)

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03258840     History of Changes
Other Study ID Numbers: 15202
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: December 2011

Keywords provided by Tehran University of Medical Sciences:
EPA
Paraoxonase 1
Paraoxonase 2
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes