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A1c Discordance in Diabetes Patients

This study has suspended participant recruitment.
(a pilot study of 7 patients did not reveal a temperature dependent difference in glycation rates)
Sponsor:
Information provided by:
Endocrine Research Society
ClinicalTrials.gov Identifier:
NCT01213277
First received: September 30, 2010
Last updated: July 25, 2011
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Other: Fast Glycator
Other: Control

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Differences in Hemoglobin Glycation Rate in Diabete Mellitus Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Endocrine Research Society:

Primary Outcome Measures:
  • Primary endpoint is to see whether they are fast glycators [ Time Frame: One Week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours [ Time Frame: One Week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: October 2010
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Other: Fast Glycator
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
 Other: Control
These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Dr. Hugh Tildesley, Providence Health Care
ClinicalTrials.gov Identifier: NCT01213277     History of Changes
Other Study ID Numbers: A1c Discordance
Study First Received: September 30, 2010
Last Updated: July 25, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Endocrine Research Society:
Diabetes Mellitus
HbA1c
Glycation Rate
Fructosamine

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013