The Study of Metabolic Syndrome in Hemodialysis Patients | NCT00632879

Studies
The Study of Metabolic Syndrome in Hemodialysis Patients

NCT00632879

Sponsor

Far Eastern Memorial Hospital

Status

Unknown status

Last Update Posted

Jul 9, 2008Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Hemodialysis
Metabolic Syndrome X
Insulin Resistance

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Mar 2008Estimated

First Submitted Date

Mar 3, 2008

First Submission Date that Met QC Criteria

Mar 3, 2008

First Posted Date

Mar 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2008

Last Update Posted Date

Jul 9, 2008Estimated

Name	Class
National Taiwan University Hospital	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who receive maintenance hemodialysis in our HD center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shao-Yu Yang, MD	Contact	886-2-89667000	1164	yangshaoyo@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Shao-Yu Yang, MD	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital	Recruiting	PanChiao, Taipei		220	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

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