Metabolic SyndromeNCT01176630
Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population
An observational study of Metabolic Syndrome, run by Winthrop University Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study subjects are on maintenance hemodialysis
Who may be able to join
- 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
Who cannot join
- Patients unwilling or unable to give informed consent to participate
- Patients with a history of thyroid disease
- Patients unable to stand upright
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital Outpatient Dialysis Unit
Mineola, New York, 11501
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, ESRD patient
- Medical subject headings
- Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of maintenance patients with at least three risk factors of metabolic syndrome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Schanler, Winthrop University Hospital
- Investigators
- Mary Schanler, MS, RD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176630
- Sponsor's protocol ID
- 10311
- Status last verified
- Feb 2012
- First submitted
- 4 Aug 2010
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population
- ClinicalTrials.gov ID
- NCT01176630
- Acronym / sponsor ID
- 10311
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, ESRD patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study subjects are on maintenance hemodialysis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients unwilling or unable to give informed consent to participate
- Patients with a history of thyroid disease
- Patients unable to stand upright
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of maintenance patients with at least three risk factors of metabolic syndrome
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Schanler, MS, RD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of maintenance patients with at least three risk factors of metabolic syndrome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.