Conditions: ESRD Diabetes
Keywords: ESRD Diabetes CAPD APD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief summary:
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) 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) 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.

Detailed description:

Arms:
arm 1: Dianeal only arm 2: Physioneal, Extraneal, Nutrineal

Interventions: intervention 1: Dianeal intervention 2: Physioneal intervention 3: Extraneal intervention 4: Nutrineal
Intervention descriptions: intervention 1: Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose) intervention 2: Physioneal 40 or Physioneal 35 intervention 3: Extraneal - 7.5% Icodextrin intervention 4: Nutrineal - 1.1% Amino Acids

Protocol document: