Multi-Center, Prospective, Randomized Trial To Demonstrate Improved Metabolic Control of PEN VS Dianeal Only in Diabetic CAPD and APD Patients - The Impendia Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 19
- 主要终点
- Change From the Baseline Value in HbA1c at Month 3 and 6
研究概览
简要总结
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.
Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.
详细描述
The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
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
- •M/F patients 18 years of age or older
- •Diagnosis of ESRD (GFR ≤ 15 mL/min)
- •CAPD or APD using only Dianealand/or Physioneal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
- •DM (Type 1 and 2) on glycemic-control medication, for 90 days
- •HbA1c > 6.0% but ≤ 12.0%
- •Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
排除标准
- •Cardiovascular event within the last 90 days
- •Ongoing clinically significant congestive heart failure (NYHA class III or IV)
- •Allergy to starch-based polymers
- •Glycogen storage disease
- •Maltose, or isomaltose intolerance
- •Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
- •Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77) at Screening.
- •Serum urea > 30 mmol/L
- •Exposure to Extraneal or Nutrineal within the last 60 days prior to Screening visit, Day
- •Receiving rosiglitazone maleate
研究组 & 干预措施
glucose sparing
PEN solutions: Nutrineal, Extraneal, and Physioneal
干预措施: Physioneal (Drug)
Non glucose sparing
Dianeal only
干预措施: Dianeal (Drug)
glucose sparing
PEN solutions: Nutrineal, Extraneal, and Physioneal
干预措施: Extraneal (Drug)
glucose sparing
PEN solutions: Nutrineal, Extraneal, and Physioneal
干预措施: Nutrineal (Drug)
结局指标
主要结局
Change From the Baseline Value in HbA1c at Month 3 and 6
时间窗: Baseline, Month 3, Month 6 (End of Study)
HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
次要结局
- Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Number of Severe Hypoglycemic Event Requiring Medical Intervention(Baseline through Month 6 (End of Study))
- Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6(Baseline and Month 6 (End of Study))
- Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6(Baseline, Month 6 (End of Study))
- Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6(Baseline, Month 3, Month 6 (End of Study))
- Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6(Baseline, Month 6 (End of Study))
- Change From Baseline of MRI Body Composition at Month 6(Baseline, Month 6 (End of Study))
- Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6(Baseline, Month 6 (End of Study))
- Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6(Baseline, Month 6 (End of Study))