Conditions: End Stage Renal Disease (ESRD) Diabetes CAPD
Keywords: ESRD Diabetes CAPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 71
Healthy volunteers: no

Brief summary:
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) 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 Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD 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.

Detailed description:

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

Interventions: intervention 1: Dianeal intervention 2: Dianeal, Extraneal, Nutrineal
Intervention descriptions: intervention 1: Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose intervention 2: Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin

Protocol document: