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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01176630
Other study ID # 10311
Secondary ID
Status Completed
Phase N/A
First received August 4, 2010
Last updated February 24, 2012
Start date August 2010
Est. completion date December 2010

Study information

Verified date February 2012
Source Winthrop University Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Winthrop University Hospital Outpatient Dialysis Unit Mineola New York

Sponsors (1)

Lead Sponsor Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of maintenance patients with at least three risk factors of metabolic syndrome 6 months No
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