Study of the Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesterol Ester Transfer Protein (CETP) in Type-1 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
研究概览
简要总结
In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down.
ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body.
The aim of this study is to determine whether it is possible to correct apoC1 function by improving glycaemic balance.
240 persons will be recruited in this study and allocated to one of two groups:
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160 Type-1 diabetes patients with uncontrolled diabetes:
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4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later.
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80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays.
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4 blood samples will be taken at the time of inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients:
- •Patients over 18 years
- •Patients with type-1 diabetes and glycated hemoglobin (HbA1C) >9%
- •Inclusion criteria controls:
- •Subjects over 18 years
- •Normal glycaemia (Fasting glycaemia <1.10 g/L) and normal lipids (Low-density lipoproteins (LDL) <1.6 g/L, triglycerides (TG) <1.5 g/L)
排除标准
- •Exclusion criteria patients:
- •Adults under guardianship
- •Patients without national health insurance
- •Pregnant or breast-feeding women
- •Progressive cancer
- •Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
- •Exclusion criteria controls:
- •Adults under guardianship
- •Persons without national health insurance
- •Pregnant or breast-feeding women
- •known dyslipidemia and/or lipid-lowering treatment
- •Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
研究组 & 干预措施
Type-1 diabetes patients
干预措施: Prise de sang (Biological)
Controls
干预措施: Prise de sang (Biological)
结局指标
主要结局
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
时间窗: 3 mois
次要结局
未报告次要终点