A1c Discordance in Diabetes Patients
Primary Purpose
Diabetes Mellitus
Status
Suspended
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fast Glycator
Control
Sponsored by
About this trial
This is an interventional screening trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, HbA1c, Glycation Rate, Fructosamine
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fast Glycator
Control
Arm Description
The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients
Outcomes
Primary Outcome Measures
Primary endpoint is to see whether they are fast glycators
Secondary Outcome Measures
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
Full Information
NCT ID
NCT01213277
First Posted
September 30, 2010
Last Updated
July 25, 2011
Sponsor
Endocrine Research Society
1. Study Identification
Unique Protocol Identification Number
NCT01213277
Brief Title
A1c Discordance in Diabetes Patients
Official Title
Differences in Hemoglobin Glycation Rate in Diabete Mellitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Suspended
Why Stopped
a pilot study of 7 patients did not reveal a temperature dependent difference in glycation rates
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2011 (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Endocrine Research Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes Mellitus, HbA1c, Glycation Rate, Fructosamine
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fast Glycator
Arm Type
Active Comparator
Arm Description
The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
Arm Title
Control
Arm Type
Active Comparator
Arm Description
These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients
Intervention Type
Other
Intervention Name(s)
Fast Glycator
Intervention Description
The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients
Primary Outcome Measure Information:
Title
Primary endpoint is to see whether they are fast glycators
Time Frame
One Week
Secondary Outcome Measure Information:
Title
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
Time Frame
One Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
16371630
Citation
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.
Results Reference
background
PubMed Identifier
9742976
Citation
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.
Results Reference
background
PubMed Identifier
12502674
Citation
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.
Results Reference
background
PubMed Identifier
12200073
Citation
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.
Results Reference
background
PubMed Identifier
15161772
Citation
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.
Results Reference
background
PubMed Identifier
9101100
Citation
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.
Results Reference
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A1c Discordance in Diabetes Patients
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