Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis
Primary Purpose
End-Stage Renal Disease
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
conventional artificial kidney (AK) vs. high flux AK
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis on ESRD under regular maintenance hemodialysis, no active infection, no allergy to chosen AK, informed consent acquired Exclusion Criteria: Not ESRD, temporary HD, active infection, during admission, allergy to chosen AK, without informed consent
Sites / Locations
- National Taiwan University Hospital, Yun-Lin BranchRecruiting
Outcomes
Primary Outcome Measures
Adiponectin and inflammatory cytokines level
Secondary Outcome Measures
Cardiovascular event
Full Information
NCT ID
NCT00155363
First Posted
September 8, 2005
Last Updated
December 19, 2005
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00155363
Brief Title
Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis
Official Title
The Impact of Conventional Hemodialysis, High Flux Hemodialysis and Hemodiafiltration on Adiponectin, Vascular Function and Clinical Prognosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
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 it's 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 34:469-474, 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 257:79-83, 1999), and coronary artery disease (CAD). However, it is shown to increase in chronic renal failure and type 1 diabetes. (European Journal of Endocrinology 148;293-300, 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 13:134-141, 2002, Clin Sci 103:137-142, 2002, Arterioscler Thromb Vasc Biol 20:1595-1599, 2000, Diabetes 52:942-947, 2003). In addition to it's ability in increasing insulin sensitivity, adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties. (European Journal of Endocrinology 148;293-300, 2003, J Hypertens 18:1207-1213, 2000). It is also associated with vascular function independent of insulin sensitivity (Diabetes Care 27:739-745, 2004). In patients with ESRD, CAD remained the leading cause of death (Kidney Int 62:1417-1422, 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. 66:355-66, 2004). Adiponectin, a large molecule (30kd), was not removed readily by conventional HD (Am J Kidney Dis 43:1047-1055, 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 43:1047-1055, 2004, Circulation 100:2473-2476, 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 13:134-141, 2002) or PD (Am J Kidney Dis 43:1047-1055, 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:
The removal efficiency of adiponectin in different hemodialysis modality.
To figure out the role of adiponectin in ESRD patients: a protective or an inflammation marker.
Patients' long term prognosis will be analyzed.
Other metabolic and inflammatory markers such as CRP, homocystine, insulin, interleukin group and their relationship with adiponectin will be investigated.
Vascular function will be assessed and its correlation with adiponectin levels will be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
conventional artificial kidney (AK) vs. high flux AK
Primary Outcome Measure Information:
Title
Adiponectin and inflammatory cytokines level
Secondary Outcome Measure Information:
Title
Cardiovascular event
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis on ESRD under regular maintenance hemodialysis, no active infection, no allergy to chosen AK, informed consent acquired
Exclusion Criteria:
Not ESRD, temporary HD, active infection, during admission, allergy to chosen AK, without informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Lun Chu, MD, MMS
Phone
0933124808
Email
plchu@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan-Dun Wu, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pei-Lun Chu, MD, MMS
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital, Yun-Lin Branch
City
Yun-Lin
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Lun Chu, MD, MMS
Email
plchu@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Pei-Lun Chu, MD, MMS
12. IPD Sharing Statement
Learn more about this trial
Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis
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