ESRDNCT01634035
Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients
An observational study of ESRD, run by Northwell Health at 1 site in United States.
Trial summary
The investigators are studying the correlation between Hba1c and the mean plasma glucose in diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess glycemic control over a 3 months duration in hemodialysis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2009
- 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 hemodialysis and diabetic population
Who may be able to join
- Age>18
- Hemodialysis and diabetic
- Lab data are available for more than 6 months
Who cannot join
- Lab data not available
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients.
The investigators are studying the correlation between Hba1c and the mean plasma glucose in diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess glycemic control over a 3 months duration in hemodialysis patients
Read the detailed description
The Hb turnover in hemodialysis population is higher than the general population leading to a general believe that HbA1c tend to underestimate mean plasma glucose.
The investigators are trying to define the correlation between mean plasma glucose and HbA1c in the hemodialysis population and trying to study the factors that could affect this correlation (dose of erythropoetin, ret count..) We are trying to see if HbA1c is a better tool to assess glycemic control over 1 month than glycemic control over 3 month.
This clinicaly will translate in obtaining HbA1c more frequently in hemodialysis patients to assess their glycemic control.
- Conditions
- ESRD
- Keywords
- glycated hemoglobin, mean plasma glucose
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diabetic hemodialysis | all patient diabetic and on hemodialysis were involved if they are on hemodialysis for more than 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure levels of plasma blood glucose and HbA1c
Measured: 6 month intervals
Secondary outcomes (1)
Measure ferritin, erythropoetin dose, reticulocytes count
Measured: 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- suzanne el-sayegh, md, Principal investigator, statenisland university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634035
- Sponsor's protocol ID
- 09-001
- Other IDs
- 09-001
- Status last verified
- Jul 2012
- First submitted
- 3 Jun 2010
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT01634035
- Acronym / sponsor ID
- 09-001
- Conditions
- ESRD
- Keywords
- glycated hemoglobin, mean plasma glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Jul 2012 (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 investigators are studying the correlation between Hba1c and the mean plasma glucose in diabetic hemodialysis patients.We are reviewing if HbA1c is a good clinical tool to assess glycemic control over a 3 months duration in hemodialysis patients
Detailed description
The Hb turnover in hemodialysis population is higher than the general population leading to a general believe that HbA1c tend to underestimate mean plasma glucose.
The investigators are trying to define the correlation between mean plasma glucose and HbA1c in the hemodialysis population and trying to study the factors that could affect this correlation (dose of erythropoetin, ret count..) We are trying to see if HbA1c is a better tool to assess glycemic control over 1 month than glycemic control over 3 month.
This clinicaly will translate in obtaining HbA1c more frequently in hemodialysis patients to assess their glycemic control.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic hemodialysis | – | –all patient diabetic and on hemodialysis were involved if they are on hemodialysis for more than 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all hemodialysis and diabetic population
Key inclusion criteria (3 listed)
- Age>18
- Hemodialysis and diabetic
- Lab data are available for more than 6 months
Key exclusion criteria (1 listed)
- Lab data not available
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
Measure levels of plasma blood glucose and HbA1c
Time frame: 6 month intervals
1 secondary outcome
Measure ferritin, erythropoetin dose, reticulocytes count
Time frame: 6 month intervals
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 6 Jul 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.
suzanne el-sayegh, md principal investigator
statenisland 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 ESRD, run by Northwell Health 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 1 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 6 Jul 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?
Measure levels of plasma blood glucose and HbA1c (time frame: 6 month intervals). 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 6 Jul 2012.