EPA Supplementation on Vascular Inflammation, and Gene Expression of PON2 in Patients With Type II Diabetes Mellitus
- Conditions
- Diabetes Mellitus Type II
- Interventions
- Dietary Supplement: EPA PlaceboDietary Supplement: EPA Supplement
- Registration Number
- NCT03258840
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EPA placebo EPA Placebo EPA- placebo softgel (Containing 2 g edible paraffin oil), 2 times/day, for 8 weeks EPA supplement EPA Supplement EPA supplement softgel (containing 2 g EPA per day), 2 times/day, for 8 weeks.
- Primary Outcome Measures
Name Time Method HbA1c Change from Baseline at 8 weeks after the intervention Hemoglobin A1c (HbA1c) measurement by related kits according their protocols
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Tehran University of Medical Sciences (TUMS), School of Nutritional Sciences and Dietetics, Department of Cellular and Molecular Nutrition
🇮🇷Tehran, Iran, Islamic Republic of