NCT00755404撤回2 期
Phase 2 Study of the Effect of a Peritoneal Dialysis Solution Containing Glucose (1.5%) and L-Carnitine (0.1%) on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement
研究概览
简要总结
The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity evaluated by measuring insulin requirement.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months
- •Have Type 2 Diabetes, diagnosed according to American Diabetes Association (fasting glucose ≥126 mg/dl and 2 h glucose at OGTT ≥200 mg/dl), and treated with multiple daily insulin injection or with HbA1c > 8.5% (No oral antidiabetic)
- •Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
- •Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
- •Have not experienced peritonitis episodes in the last 3 months
- •Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
- •Be treated with 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
- •Have Kt/V urea measurement > 1.7 per week in a previous test performed within 3 months that should be confirmed at Baseline Visit
- •Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
- •Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit
- •Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit
- •Be treated by the participating clinical Investigator for a period of at least three months
- •Have understood and signed the Informed Consent Form.
排除标准
- •Have a history of drug or alcohol abuse in the six months prior to entering the protocol
- •Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C < 8.5%
- •Be in treatment with androgens
- •Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
- •Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
- •Have a history of congestive heart failure and clinically significant arrhythmia
- •Have an history of epilepsy or any CNS disease
- •Have malignancy within the past 5 years, including lymphoproliferative disorders
- •Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug
- •Have a history of L-Carnitine therapy or use in the month prior to entering the protocol
- •Have used any investigational drug in the 3 months prior to entering the protocol
- •Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
研究组 & 干预措施
A
Active Comparator
干预措施: PD Solution (Drug)
B
Experimental
干预措施: PD solution containing L-carnitine (Drug)
结局指标
主要结局
To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement
时间窗: time 0, 6 months
次要结局
- To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile(4 weeks, time 0, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months)
- To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements)(2 weeks, time 0, 3 months, 6 months)
研究者
研究点 (8)
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