Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Postprandial change in leukocyte activation
研究概览
简要总结
In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.
详细描述
Cardiovascular disease (CVD) is number one killer in the Netherlands. Insulin resistance and dyslipideima are the main causes of CVD. Recently, we have shown that there is an acute leukocyte activation after an oral glucose tolerance test (OGTT) in patients with newly-diagnosed diabets mellitus type 2 (T2DM). Leukocyte activation is an important and obligatory aspect in the process of atherosclerosis. Complement system is another important inflammatory component in atherosclerosis, which becomes activated in the postprandial phase.
In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent
- •Aged 45-65 years
- •BMI < 35 kg/m2
排除标准
- •Emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. Subjects who are not able to understand the patient information
- •Diabetes mellitus treated with oral antidiabetic medicine
- •Type 1 diabetes mellitus
- •Peripheral artery and/or coronary disease
- •Untreated hypertension
- •Alcohol use > 2 units/day
- •Aberrations in kidney, liver and thyroid function
- •Use of any experimental medication within 6 months of the study
- •The use of immunosuppressive drugs
结局指标
主要结局
Postprandial change in leukocyte activation
时间窗: area under the curve during 2 hours
Leukocyte activation is determined by flow cytometry, using fluorescent labelled antibodies: FITC-conjugated anti-CD66b and PE-conjugated anti-CD11b, expressed in mean fluorescence intensity in arbitrary units. The difference in postprandial response, expressed as area under the curve, between patients with T2DM, FCH and healthy controls is determined using ANOVA.
次要结局
- Correlation between chronic glycemia and leukocyte activation(area under the curve during 2 hours)
- Correlation between acute glycemia and leukocyte activation(area under the curve during 2 hours)
研究者
M.A. de Vries
MD
Sint Franciscus Gasthuis