IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients

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.

Timeline

Start

2008-04

Primary completion

2011-07

Completion

2011-07

Publications

• Background Gokal R. Taking peritoneal dialysis beyond the year 2000. Perit Dial Int. 1999;19 Suppl 3:S35-42; discussion S43.
• Background Delarue J, Maingourd C, Couet C, Vidal S, Bagros P, Lamisse F. Effects of oral glucose on intermediary metabolism in continuous ambulatory peritoneal dialysis patients versus healthy subjects. Perit Dial Int. 1998 Sep-Oct;18(5):505-11.
• Background Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
• Background Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. doi: 10.1093/ndt/gfi197. Epub 2005 Oct 12.
• Background Nundy S, Baron JH. The use of neutral red as a peroperative test of vagal innervation. Scand J Gastroenterol. 1975;10(8):847-50.
• Background Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. doi: 10.1159/000086553. Epub 2005 Jun 23.

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