NCT00155363

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

December 20, 2005

Status Verified

June 1, 2005

First QC Date

September 8, 2005

Last Update Submit

December 19, 2005

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adiponectin and inflammatory cytokines level

Secondary Outcomes (1)

  • Cardiovascular event

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis on ESRD under regular maintenance hemodialysis, no active infection, no allergy to chosen AK, informed consent acquired

You may not qualify if:

  • Not ESRD, temporary HD, active infection, during admission, allergy to chosen AK, without informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kwan-Dun Wu, MD, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR
  • Pei-Lun Chu, MD, MMS

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Lun Chu, MD, MMS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Last Updated

December 20, 2005

Record last verified: 2005-06

Locations