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The Study of Metabolic Syndrome in Hemodialysis Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632879
First Posted: March 11, 2008
Last Update Posted: July 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Taiwan University Hospital
Information provided by:
Far Eastern Memorial Hospital
  Purpose

Metabolic syndrome (MS), comprised of central obesity, glucose intolerance, hyperinsulinemia, low HDL-cholesterol (HDL-C), high triglyceride (TG) and hypertension, results in markedly increased risk for cardiovascular disease in the general population. The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) report recommended the use of five variables for the diagnosis of the MS including waist circumference (WC), serum TG concentration, serum HDL-C concentration, blood pressure and fasting glucose concentration. A waist circumference of 80 cm in women and 90 cm in men would better identify those with the MS in Asian populations. However, the studies of modified asian criteria of metabolic syndrome in hemodialysis (HD) patients are scarce.

We will perform prevalence investigation, cross-sectional study, and prospective investigation for metabolic syndrome in our HD patients (around 360 at present). We will enroll all the patients who receive maintenance HD more than three months in our HD center. The patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study. Biochemistry and anthropometric parameters including HDL-C, TG, insulin resistance index, high sensitivity C-reactive protein and WC will be collected and analyzed. We will also prospectively establish the mortality and hospitalization indices of these patients, to study the prognosis of HD patient with or without metabolic syndrome.

This study will be helpful to understand whether the application of a modified criteria of metabolic syndrome in HD patients is capable to predict cardiovascular events, hospitalization and mortality rates.


Condition
Hemodialysis Metabolic Syndrome X Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study of Metabolic Syndrome in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Biospecimen Retention:   Samples With DNA
Blood samples are collected for analysis

Estimated Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: March 2008
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who receive maintenance hemodialysis in our HD center
Criteria

Inclusion Criteria:

  • We will enroll all the patients who receive maintenance HD more than three months in our HD center.

Exclusion Criteria:

  • The patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632879


Contacts
Contact: Shao-Yu Yang, MD 886-2-89667000 ext 1164 yangshaoyo@yahoo.com.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
PanChiao, Taipei, Taiwan, 220
Contact: Shao-Yu Yang, MD    886-2-89667000 ext 1164    yangshaoyo@yahoo.com.tw   
Sponsors and Collaborators
Far Eastern Memorial Hospital
National Taiwan University Hospital
Investigators
Principal Investigator: Shao-Yu Yang, MD Far Eastern Memorial Hospital
  More Information

Responsible Party: Shao-Yu Yang/Attending Physician, Far Eastern Memorial Hospital and National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00632879     History of Changes
Other Study ID Numbers: 96011
First Submitted: March 3, 2008
First Posted: March 11, 2008
Last Update Posted: July 9, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases