The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure

February 19, 2020 updated by: Reem Mohammad Alamoudi
The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. We would like to evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on HbA1c

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

50

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Our target population is patients with diabetes and impaired renal function. This study will include 80 adult patients with type1 or type 2 diabetes; 20 with normal serum creatinine, 40 with renal failure in the predialysis stage (20 with stage 3 and 4 CKD [GFR 0f 20-40] and 20 with stage 5 CKD not yet on hemodialysis [GFR <20]), and 20 on hemodialysis. All patients should be comfortable and committed to doing self-glucose monitoring.

Description

Inclusion Criteria:

All patients >18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing

Exclusion Criteria:

  • Pregnancy
  • Having received a blood transfusion with in the preceding three months
  • Known to have any hereditary or hemolytic anemia
  • On a medication known to interfere with HbA1c assay (opiates, acetaminophen, vitamin C, vitamin E) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug.
  • Having a blood hemoglobin <7 mg/dl
  • Bilirubin level >20mg/dL or a triglyceride level > 250mg/dL
  • Alcohol addiction

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
Normal renal function
Stage 2 and 4 and 5 chronic kidney disease
End stage renal disease on hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation
Time Frame: three months
The quantitative correlation between mean blood glucose and HbA1c in patients with diabetes and renal failure
three months

Collaborators and Investigators

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

Sponsor

Reem Mohammad Alamoudi

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

July 1, 2012

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (ESTIMATE)

September 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC08/107/A

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.

Clinical Trials on Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe