Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mary Schanler, Winthrop University Hospital

ClinicalTrials.gov Identifier:

NCT01176630

First received: August 4, 2010

Last updated: February 24, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2010

Last Updated Date

February 24, 2012

Start Date ^ICMJE

August 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent of maintenance patients with at least three risk factors of metabolic syndrome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01176630 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population

Official Title ^ICMJE

Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population

Brief Summary

The study is a survey to answer the specific question, "What is the prevalence of metabolic syndrome in maintenance hemodialysis patients?" Metabolic syndrome is a cluster of conditions that increase an individual's risk for developing cardiovascular disease and diabetes.

Detailed Description

Risk factors for metabolic syndrome will be collected for each consented patient. They include elevated serum triglycerides, reduced HDL cholesterol, hypertension, elevated fasting blood sugar concentration and abdominal obesity. The investigator will measure waist circumference of each consented patient in a secure area according to standardized procedures. The other data is available from the patient's medical record.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

All study subjects are on maintenance hemodialysis

Condition ^ICMJE

Metabolic Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

108

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients undergoing maintenance hemodialysis equal to or greater than 3 months
Patient at lest 18 years of age
Availability of all data in the medical record for classification of the metabolic syndrome, including serum triglycerides, serum HDL-cholesterol, systolic BP and diastolic BP, and serum glucose

Exclusion Criteria:

Patients unwilling or unable to give informed consent to participate
Patients with a history of thyroid disease
Patients unable to stand upright

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01176630

Other Study ID Numbers ^ICMJE

10311

Has Data Monitoring Committee

Responsible Party

Mary Schanler, Winthrop University Hospital

Study Sponsor ^ICMJE

Winthrop University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mary Schanler, MS, RD

Winthrop University Hospital

Information Provided By

Winthrop University Hospital

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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