The Study of Metabolic Syndrome in Hemodialysis Patients

Insulin Resistance Clinical Trial

Official title:

The Study of Metabolic Syndrome in Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00632879
• Other study ID #: 96011
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2008
• Last updated: July 7, 2008
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2008
• Source: Far Eastern Memorial Hospital
• Contact: Shao-Yu Yang, MD
• Phone: 886-2-89667000
• Email: yangshaoyo[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemodialysis
• Insulin Resistance
• Metabolic Syndrome X
• Syndrome

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	PanChiao, Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,