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A1c Discordance in Diabetes Patients

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ClinicalTrials.gov Identifier: NCT01213277
Recruitment Status : Suspended (a pilot study of 7 patients did not reveal a temperature dependent difference in glycation rates)
First Posted : October 1, 2010
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Endocrine Research Society

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Other: Fast Glycator Other: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Differences in Hemoglobin Glycation Rate in Diabete Mellitus Patients
Study Start Date : October 2010
Primary Completion Date : May 2011

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
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




Primary Outcome Measures :
  1. Primary endpoint is to see whether they are fast glycators [ Time Frame: One Week ]

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


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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Dr. Hugh Tildesley, Providence Health Care
ClinicalTrials.gov Identifier: NCT01213277     History of Changes
Other Study ID Numbers: A1c Discordance
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: September 2010

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