Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time hyperglycemia
研究概览
简要总结
As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.
The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:
- LDL oxidation
- HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients who have provided written consent
- •Patients with national health insurance cover
- •Patients with T1D
- •T1D Patients treated with insulin via a pump or multiple injections
- •HbA1c < 9.5 %
- •Control patients
- •Normal fasting glycaemia (< 6.1 mmol/L)
- •Age > 18 years, matched for sex and age with T1D patients
- •All patients
- •Normal serum HDL cholesterol (> 1.04 mmol/L in men, > 1.30 mmol:L in women)
- •Serum LDL cholesterol < 5 mmol/L
- •triglyceridemia < 1.7 mmol/L
- •Waist circumference < 102 cm in men, < 88 cm in women
排除标准
- •Kidney failure (Creatinine clearance< 60 ml/min/1.73 m2)
- •Liver failure
- •Dysthyroidism
- •Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month
- •Antioxidant (vitamin E, dietary supplements, DHA)
- •Pregnancy of more than 15d
研究组 & 干预措施
patients with type-1 diabetes
干预措施: installation of Holter (Device)
patients with type-1 diabetes
干预措施: blood sample (Biological)
patients with type-1 diabetes
干预措施: urine sample (Biological)
Controls
干预措施: blood sample (Biological)
Controls
干预措施: urine sample (Biological)
结局指标
主要结局
Time hyperglycemia
时间窗: through study completion, an average of 7 days
Amplitude of glycemic variations
时间窗: through study completion, an average of 7 days
Average blood glucose
时间窗: through study completion, an average of 7 days
Time hypoglycemia
时间窗: through study completion, an average of 7 days
次要结局
未报告次要终点