- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176630
Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population
February 24, 2012 updated by: Mary Schanler, Winthrop University Hospital
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.
Study Overview
Status
Completed
Conditions
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
Observational
Enrollment (Actual)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Mineola, New York, United States, 11501
- Winthrop University Hospital Outpatient Dialysis Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All study subjects are on maintenance hemodialysis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of maintenance patients with at least three risk factors of metabolic syndrome
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary Schanler, MS, RD, Winthrop University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 4, 2010
First Submitted That Met QC Criteria
August 4, 2010
First Posted (Estimate)
August 6, 2010
Study Record Updates
Last Update Posted (Estimate)
February 27, 2012
Last Update Submitted That Met QC Criteria
February 24, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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