The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Fractional excretion of sodium
研究概览
简要总结
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.
详细描述
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.
On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.
Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC) will be measured to evaluate channel activity in the nephron.
Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •minimum 40 years
- •Chronic Kidney disease
- •Estimated GFR (eGFR) between 30 and 90 ml/min
- •Diabetes Mellitus type II
排除标准
- •Nephrotic Syndrome
- •Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease
- •Neoplastic disease
- •Alcohol abuse,
- •Drug abuse
- •Pregnancy or nursing
- •Blood donation within a month before examination
- •Hgb < 6,0
研究组 & 干预措施
Atorvastatin
干预措施: Atorvastatin (Drug)
Placebo
干预措施: Unikalk (Drug)
结局指标
主要结局
Fractional excretion of sodium
时间窗: 5 days treatment
次要结局
- Systolic blood pressure(5 days)
- Plasma renin concentration(5 days)
- Arterial stiffness(5 days)
- Plasma angiotensin II concentration(5 days)
- Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)(5 days)
- Augmentations index(5 days)
研究者
Erling Bjerregaard Pedersen
professor chief physician
Regional Hospital Holstebro