Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients

July 2, 2012 updated by: Northwell Health

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

159

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

    • New York
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital

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 hemodialysis and diabetic population

Description

Inclusion Criteria:

  • Age>18
  • Hemodialysis and diabetic
  • Lab data are available for more than 6 months

Exclusion Criteria:

  • Lab data not available

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

Cohorts and Interventions

Group / Cohort
diabetic hemodialysis
all patient diabetic and on hemodialysis were involved if they are on hemodialysis for more than 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure levels of plasma blood glucose and HbA1c
Time Frame: 6 month intervals
6 month intervals

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure ferritin, erythropoetin dose, reticulocytes count
Time Frame: 6 month intervals
6 month intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: suzanne el-sayegh, md, statenisland 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

March 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

July 2, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 2, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 09-001 (SIUH IRB)

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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