NCT01176630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

August 4, 2010

Last Update Submit

February 24, 2012

Conditions

Keywords

metabolic syndrome, ESRD patient

Outcome Measures

Primary Outcomes (1)

  • Percent of maintenance patients with at least three risk factors of metabolic syndrome

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All study subjects are on maintenance hemodialysis

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital Outpatient Dialysis Unit

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mary Schanler, MS, RD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrative Dietitian

Study Record Dates

First Submitted

August 4, 2010

First Posted

August 6, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations