Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients

ESRD Clinical Trial

Official title:

Correlation Between Glycated Hemoglobin and Mean Plasma Glucose in Hemodialysis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634035
• Other study ID #: 09-001
• Secondary ID: 09-001
• Status: Completed
• Phase: N/A
• First received: June 3, 2010
• Last updated: July 2, 2012
• Start date: March 2009
• Est. completion date: May 2009

Study information

• Verified date: July 2012
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18

• Hemodialysis and diabetic

• Lab data are available for more than 6 months

Exclusion Criteria:

• Lab data not available

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• ESRD

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure levels of plasma blood glucose and HbA1c		6 month intervals	No
Secondary	Measure ferritin, erythropoetin dose, reticulocytes count		6 month intervals	No