Clinical trial NCT03258840: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type II
Keywords: EPA
Paraoxonase 1
Paraoxonase 2
Type 2 diabetes
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: Change from Baseline at 8 weeks after the intervention
Secondary outcomes:
measure: PON2 gene expression
timeFrame: Baseline, 8 weeks after the intervention
measure: Systolic blood pressure
timeFrame: Change frome baseline at 8 weeks
measure: Diastolic blood pressure
timeFrame: Change frome baseline at 8 weeks
measure: serum paraoxonase-1(PON-1) activity
timeFrame: Baseline, 8 weeks after the intervention
measure: PON1/HDL-c Ratio
timeFrame: Baseline, 8 weeks after the intervention
measure: serum paraoxonase lactonase (PON-HCTLase) activity
timeFrame: Baseline, 8 weeks after the intervention
measure: HDL-c
timeFrame: Baseline, 8 weeks after the intervention
measure: FBS
timeFrame: Baseline, 8 weeks after the intervention
measure: HDL2-c
timeFrame: Baseline, 8 weeks after the intervention
measure: HDL3-c
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum apo B
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum apo A-I
timeFrame: Baseline, 8 weeks after the intervention
measure: apo B/apo A-I Ratio
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum methionine
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum malondialdehyde (MDA)
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum homocysteine (Hcy)
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum sE-Selectin
timeFrame: Baseline, 8 weeks after the intervention
measure: sVCAM-1
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum cysteine
timeFrame: Baseline, 8 weeks after the intervention
measure: Serum Lpa
timeFrame: Baseline, 8 weeks after the intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition
Study officials:
affiliation: Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
name: Mohammad Hassan Golzari, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
name: Mahmoud Djallali, Ph.D
role: STUDY_CHAIR
affiliation: Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
name: Saeed Hosseini, MD,Ph.D
role: STUDY_DIRECTOR
References:
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.