A1c Discordance in Diabetes Patients

July 25, 2011 updated by: Endocrine Research Society

Differences in Hemoglobin Glycation Rate in Diabete Mellitus Patients

HbA1c is used as a gold standard to see whether patients have optimal glycemic control. Today, many physicians rely solely on HbA1c to change medication. However, there is a select group of patients that have low average glucose levels but high HbA1c levels. The investigators believe that these patients are fast glycators meaning that they incorporate sugar into their hemoglobin faster than normal. The investigators want to determine whether these patients are fast glycators.

Study Overview

Status

Suspended

Conditions

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

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

23 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with diabetes
  • Patients who test their sugar levels at least 3 times daily
  • Recorded diary of sugar levels for the past month
  • Willingness to have blood drawn
  • Willingness to allow their blood sugar diary to be photocopied
  • Estimated average glucose as derived from A1c is ≥ 4 mmol from measured glucose from self-monitoring blood glucose testing

Exclusion Criteria:

  • Patient with medical conditions that may affect their study participation or results will be excluded.
  • Patients who are anemic
  • Renal insufficient with a serum creatinine level > 200 μmol/L

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fast Glycator
The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
Active Comparator: Control
These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients
These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary endpoint is to see whether they are fast glycators
Time Frame: One Week
One Week

Secondary Outcome Measures

Outcome Measure
Time Frame
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
Time Frame: One Week
One Week

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2010

Primary Completion

May 1, 2011

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 1, 2010

Study Record Updates

Last Update Posted (Estimate)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

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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