跳至主要内容
临床试验/NCT03258840
NCT03258840已完成不适用

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

Tehran University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
HbA1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

EPA placebo

Placebo Comparator

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

干预措施: EPA Placebo (Dietary Supplement)

EPA supplement

Active Comparator

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

干预措施: EPA Supplement (Dietary Supplement)

结局指标

主要结局

HbA1c

时间窗: Change from Baseline at 8 weeks after the intervention

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

次要结局

  • PON2 gene expression(Baseline, 8 weeks after the intervention)
  • Systolic blood pressure(Change frome baseline at 8 weeks)
  • Diastolic blood pressure(Change frome baseline at 8 weeks)
  • serum paraoxonase-1(PON-1) activity(Baseline, 8 weeks after the intervention)
  • PON1/HDL-c Ratio(Baseline, 8 weeks after the intervention)
  • serum paraoxonase lactonase (PON-HCTLase) activity(Baseline, 8 weeks after the intervention)
  • HDL-c(Baseline, 8 weeks after the intervention)
  • FBS(Baseline, 8 weeks after the intervention)
  • HDL2-c(Baseline, 8 weeks after the intervention)
  • HDL3-c(Baseline, 8 weeks after the intervention)
  • Serum apo B(Baseline, 8 weeks after the intervention)
  • Serum apo A-I(Baseline, 8 weeks after the intervention)
  • apo B/apo A-I Ratio(Baseline, 8 weeks after the intervention)
  • Serum methionine(Baseline, 8 weeks after the intervention)
  • Serum malondialdehyde (MDA)(Baseline, 8 weeks after the intervention)
  • Serum homocysteine (Hcy)(Baseline, 8 weeks after the intervention)
  • Serum sE-Selectin(Baseline, 8 weeks after the intervention)
  • sVCAM-1(Baseline, 8 weeks after the intervention)
  • Serum cysteine(Baseline, 8 weeks after the intervention)
  • Serum Lpa(Baseline, 8 weeks after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

EPA Supplementation on Vascular Inflammation, and... | 临床试验