The Impact of Omega-3 Supplementation on Acylation Stimulating Protein(ASP), Retinol-binding Protein 4 (RBP4) and Lipocalin-2 (LCN2) Gene Expression of ASP Receptor (C5L2) in WBC of Patient With Diabetes Type 2
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- serum total cholesterol
研究概览
简要总结
The aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics
详细描述
Adipose tissue is recognized as an important endocrine organ in human. Not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years. Acylation stimulating protein(ASP), Retinol-binding protein 4 (RBP4) and lipocalin-2 (LCN2) are circulating adipokines elevated in diabetes. C5L2 is a G-protein-coupled receptor. activation of C5L2 by ASP, has been shown. Fatty acids may influence the expression of adipokines. Epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes. Because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participation
- •Diabetic patients 30-65 years old
- •Body mass index in the range 18.5-40
- •Avoidance of dietary supplements
- •vitamins and herbal products at least 2 weeks before and throughout the intervention
排除标准
- •people who have used omega-3 supplements in last 3 months
- •Having chronic renal disease
- •hepatic disease
- •gastrointestinal disease
- •hematological disorders
- •hypothyroidism or hyperthyroidism
- •Treatment with Orlistat or sibutramine for weight loss
- •Pregnancy and lactation
- •Treatment with insulin or Thiazolidinediones
结局指标
主要结局
serum total cholesterol
时间窗: change from baseline at 10 weeks
serum High-density lipoprotein (HDL) cholesterol
时间窗: change from baseline at 10 weeks
serum Low-density lipoprotein (LDL) cholesterol
时间窗: change from baseline at 10 weeks
serum triglycerides (TG) level
时间窗: change from baseline at 10 weeks
postprandial triglycerides
时间窗: change from baseline at 10 weeks
complete blood count(CBC)
时间窗: change from baseline at 10 weeks
fasting plasma glucose(FPG)
时间窗: change from baseline at 10 weeks
Glycated hemoglobin (Hb A1c)
时间窗: change from baseline at 10 weeks
acylation stimulating protein (ASP)
时间窗: change from baseline at 10 weeks
lipocalin-2 (LCN2)
时间窗: change from baseline at 10 weeks
Retinol-binding protein 4 (RBP4)
时间窗: change from baseline at 10 weeks
non-esterified fatty acids (NEFA)
时间窗: change from baseline at 10 weeks
insulin
时间窗: change from baseline at 10 weeks
postprandial ASP
时间窗: chage from baseline at 10 weeks
次要结局
- gene expression of C5L2(change from baseline at 10 weeks)