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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
  Purpose

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.


Condition
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Winthrop University Hospital:

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

Enrollment: 108
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All study subjects are on maintenance hemodialysis

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176630

Locations
United States, New York
Winthrop University Hospital Outpatient Dialysis Unit
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Mary Schanler, MS, RD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Mary Schanler, Administrative Dietitian, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01176630     History of Changes
Other Study ID Numbers: 10311
Study First Received: August 4, 2010
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
metabolic syndrome, ESRD patient

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

ClinicalTrials.gov processed this record on June 17, 2013