A1c Discordance in Diabetes Patients

Diabetes Mellitus Clinical Trial

Official title:

Differences in Hemoglobin Glycation Rate in Diabete Mellitus Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01213277
• Other study ID #: A1c Discordance
• Status: Suspended
• Phase: N/A
• First received: September 30, 2010
• Last updated: July 25, 2011
• Start date: October 2010

Study information

• Verified date: September 2010
• Source: Endocrine Research Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Fast Glycator
The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
• Control
These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endocrine Research Society

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is to see whether they are fast glycators		One Week	No
Secondary	A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours		One Week	Yes