- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213277
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
Intervention / Treatment
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.
Sponsor
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
- Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.
- Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
- Cohen RM, Holmes YR, Chenier TC, Joiner CH. Discordance between HbA1c and fructosamine: evidence for a glycosylation gap and its relation to diabetic nephropathy. Diabetes Care. 2003 Jan;26(1):163-7. doi: 10.2337/diacare.26.1.163.
- Hempe JM, Gomez R, McCarter RJ Jr, Chalew SA. High and low hemoglobin glycation phenotypes in type 1 diabetes: a challenge for interpretation of glycemic control. J Diabetes Complications. 2002 Sep-Oct;16(5):313-20. doi: 10.1016/s1056-8727(01)00227-6.
- McCarter RJ, Hempe JM, Gomez R, Chalew SA. Biological variation in HbA1c predicts risk of retinopathy and nephropathy in type 1 diabetes. Diabetes Care. 2004 Jun;27(6):1259-64. doi: 10.2337/diacare.27.6.1259.
- Gould BJ, Davie SJ, Yudkin JS. Investigation of the mechanism underlying the variability of glycated haemoglobin in non-diabetic subjects not related to glycaemia. Clin Chim Acta. 1997 Apr 4;260(1):49-64. doi: 10.1016/s0009-8981(96)06508-4.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1c Discordance
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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