NCT03561571已完成不适用
Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women
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
- 32
- 试验地点
- 2
- 主要终点
- fasting thromboxane B2 concentration
研究概览
简要总结
To investigate in vitro the effect of triglyceride rich lipoproteins (TGRL) obtained in type 2 diabetic women in the fasting state and following a randomized isocaloric lipid rich breakfast on control human platelets
Randomized Comparison of butter versus chocolate spread in 2 groups of 15 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal women
- •HbA1c ≥6,5 ou ≤10%
- •27 ≤ BMI ≤40 kg/m2
排除标准
- •Insulin therapy
- •fibrates or Omega 3 fatty acids supplements
- •Hormonal replacement therapy of menopause
- •Glycemia > 16 mmol/l
- •Alcohol abuse (≥3 Unit/day)
- •Special dietary habits
- •History of bariatric surgery
研究组 & 干预措施
Butter based breakfast
Active Comparator
干预措施: butter based breakfast (Other)
Chocolate spread based breakfast
Active Comparator
干预措施: Chocolate spread based breakfast (Other)
结局指标
主要结局
fasting thromboxane B2 concentration
时间窗: Hour 0
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
after breakfast thromboxane B2 concentration
时间窗: 4 hours
ex vivo experiment : TGRL obtained by preparative Unesterified cholesterol (UC) incubated with control human platelets
次要结局
- measurement of fasting platelet activation by turbidimetric method(Hour 0)
- measurement of post prandial platelet activation by turbidimetric method(4 Hours)
- fasting lipidomic composition of triglyceride rich lipoproteins(Hour 0)
- post prandial lipidomic composition of triglyceride rich lipoproteins(4 Hours)
研究者
研究点 (2)
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