A1c Discordance in Diabetes Patients

NCT ID: NCT01213277

Last Updated: 2011-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Fast Glycator

The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators

Group Type ACTIVE_COMPARATOR

Fast Glycator

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients

Interventions

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Fast Glycator

The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators

Intervention Type OTHER

Control

These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endocrine Research Society

OTHER

Sponsor Role lead

Responsible Party

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Providence Health Care

References

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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.

Reference Type BACKGROUND
PMID: 16371630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9742976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12502674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12200073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15161772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9101100 (View on PubMed)

Other Identifiers

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A1c Discordance

Identifier Type: -

Identifier Source: org_study_id

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