Viewing Study NCT00155363



Ignite Creation Date: 2024-05-05 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00155363
Status: UNKNOWN
Last Update Posted: 2005-12-20
First Post: 2005-09-08

Brief Title: Effect of Different Hemodialysis Modality on AdiponectinVascular Function and Clinical Prognosis
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: The Impact of Conventional Hemodialysis High Flux Hemodialysis and Hemodiafiltration on Adiponectin Vascular Function and Clinical Prognosis
Status: UNKNOWN
Status Verified Date: 2005-06
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Adiponectin an adipose tissue derived protein with anti-inflammatory properties that is secreted from adipose tissue is associated with insulin resistance It has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing hemodialysis Adiponectin levels were inversely related to body mass index values plasma leptin levels insulin levels serum triglyceride levels and homeostatic model assessment index values In addition to its ability in increasing insulin sensitivity adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties In patients with ESRD renal replacement method was either peritoneal dialysis or HD High efficient dialysis methods such as high flux HD and HDF had been used more and more popularly High flux HD and HDF have the advantages in middle to large molecule removal and better hemodynamic stability Better clinical prognosis has been shown in patients undergoing high flux HD or HDF Although studies have demonstrated that the plasma adiponectin levels were elevated in patients receiving HD whether different dialysis modality will interfere the plasma adiponectin levels and patients prognosis remain unknown The current project is planned to investigate the effects of different HD modality on the plasma adiponectin levels and its correlation other serum inflammatory markers and vascular function Patients long term prognosis will also be assessed in the present study
Detailed Description: Adiponectin a cytokine with anti-inflammatory properties that is secreted from adipose tissue is associated with insulin resistance Horm Metab Res 34469-474 2002 The plasma adiponectin level has been reported to be decreased in some insulin-resistant states such as obesity and type 2 diabetes Biochem Biophys Res Commun 25779-83 1999 and coronary artery disease CAD However it is shown to increase in chronic renal failure and type 1 diabetes European Journal of Endocrinology 148293-300 2003 Plasma adiponectin levels were inversely related to body mass index values plasma leptin levels insulin levels serum triglyceride levels and homeostatic model assessment index values J Am Soc Nephrol 13134-141 2002 Clin Sci 103137-142 2002 Arterioscler Thromb Vasc Biol 201595-1599 2000 Diabetes 52942-947 2003 In addition to its ability in increasing insulin sensitivity adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties European Journal of Endocrinology 148293-300 2003 J Hypertens 181207-1213 2000 It is also associated with vascular function independent of insulin sensitivity Diabetes Care 27739-745 2004 In patients with ESRD CAD remained the leading cause of death Kidney Int 621417-1422 2002 regardless of different renal replacement methods peritoneal dialysis or HD and the modality it uses In recent years with the development of high flux HD and HDF the dialyzer has gained much progress in its efficiency High flux HD and HDF have the advantages in middle to large molecule removal and better hemodynamic stability Kidney Int 66355-66 2004 Adiponectin a large molecule 30kd was not removed readily by conventional HD Am J Kidney Dis 431047-1055 2004 but it might be removed by high flux and HDF

Due to undialyzable characteristic and decreased excretion from impaired renal function Am J Kidney Dis 431047-1055 2004 Circulation 1002473-2476 1999 adiponectin level is elevated in patients receiving HD and PD Adiponectin has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing HD J Am Soc Nephrol 13134-141 2002 or PD Am J Kidney Dis 431047-1055 2004 Weather the elevation of adiponectin level is a protective factor of cardiovascular risk or just a reactor from inflammatory condition remains unknown This project was aimed to study the removal efficiency of adiponectin in high flux HD and HDF and also the consequence of long term prognosis Besides other metabolic and inflammatory markers such as CRP homocystine insulin interleukin group will be measured Adiponectin an adipose tissue derived protein with anti-inflammatory properties that is secreted from adipose tissue is associated with insulin resistance So this project was aimed to study

1 The removal efficiency of adiponectin in different hemodialysis modality
2 To figure out the role of adiponectin in ESRD patients a protective or an inflammation marker
3 Patients long term prognosis will be analyzed
4 Other metabolic and inflammatory markers such as CRP homocystine insulin interleukin group and their relationship with adiponectin will be investigated
5 Vascular function will be assessed and its correlation with adiponectin levels will be studied

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None