The Study of Metabolic Syndrome in Hemodialysis Patients

NCT00632879 | Unknown

• 1 other identifier: 96011
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis; Metabolic Syndrome X; Insulin Resistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who receive maintenance hemodialysis in our HD center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

Far Eastern Memorial Hospital

PanChiao, Taipei, 220, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected for analysis

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shao-Yu Yang, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao-Yu Yang, MD

CONTACT

886-2-89667000; yangshaoyo@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 11, 2008
• Study Start: March 1, 2007
• Study Completion: March 1, 2008
• Last Updated: July 9, 2008

Record last verified: 2008-07

Locations

TW (1)