Effects of Different Insulin Regimens on Artery Compliance, Endothelium Function and Autonomic Cardiac Function in Patients With Poorly Controlled Type 2 Diabetes: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Vago-sympathetic activity, arterial stiffness, endothelial function
研究概览
简要总结
Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.
详细描述
Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients.
The aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function.
Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them.
Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and BodPod®.
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
- None
入排标准
- 年龄范围
- 30 Years 至 72 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent patient
- •Adults from 30 to 72 years old
- •type 2 diabetic patients for at least 1 year
- •able to self measure capillary blood glucose
- •body mass index 20-37 kg/m²,
- •HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months
- •anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months
- •Exclusion criteria:
- •pregnancy
- •other antidiabetic medication in the previous 2 months,
- •anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months,
- •insulin allergy,
- •uncontrolled preproliferative or proliferative diabetic retinopathy
- •uncontrolled hypertension
- •renal failure(creatinin clearance <40 ml/min)
- •hepatocellular deficiency (prothrombin time <70%)
- •peripheral occlusive arterial disease
- •cardiac arrhythmia
排除标准
- 未提供
研究组 & 干预措施
detemir
Insulin detemir at dinner or bedtime
干预措施: Insulin (Drug)
aspart
Insulin aspart before each meal
干预措施: Insulin (Drug)
detemir and aspart
干预措施: Insulin (Drug)
结局指标
主要结局
Vago-sympathetic activity, arterial stiffness, endothelial function
时间窗: 4-5 Weeks
次要结局
未报告次要终点
