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Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01176630
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : February 27, 2012
Sponsor:
Information provided by (Responsible Party):
Mary Schanler, Winthrop University Hospital

Study Description
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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.

Condition or disease
Metabolic Syndrome

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 Design
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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population
Study Start Date : August 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Percent of maintenance patients with at least three risk factors of metabolic syndrome [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176630


Locations
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United States, New York
Winthrop University Hospital Outpatient Dialysis Unit
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
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Principal Investigator: Mary Schanler, MS, RD Winthrop University Hospital
More Information
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Responsible Party: Mary Schanler, Administrative Dietitian, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01176630    
Other Study ID Numbers: 10311
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012
Keywords provided by Mary Schanler, Winthrop University Hospital:
metabolic syndrome, ESRD patient
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases