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A1c Discordance in Diabetes Patients

Primary Purpose

Diabetes Mellitus

Status
Suspended
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fast Glycator
Control
Sponsored by
Endocrine Research Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, HbA1c, Glycation Rate, Fructosamine

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 30, 2010
    Last Updated
    July 25, 2011
    Sponsor
    Endocrine Research Society
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    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
    background

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