Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis

December 19, 2005 updated by: National Taiwan University Hospital

The Impact of Conventional Hemodialysis, High Flux Hemodialysis and Hemodiafiltration on Adiponectin, Vascular Function and Clinical Prognosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  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 Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Yun-Lin, Taiwan
        • Recruiting
        • National Taiwan University Hospital, Yun-Lin branch
        • Contact:
        • Principal Investigator:
          • Pei-Lun Chu, MD, MMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adiponectin and inflammatory cytokines level

Secondary Outcome Measures

Outcome Measure
Cardiovascular event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Kwan-Dun Wu, MD, PhD, National Taiwan University Hospital
  • Principal Investigator: Pei-Lun Chu, MD, MMS, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 20, 2005

Last Update Submitted That Met QC Criteria

December 19, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9361701293

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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