NCT01213277

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.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
25

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

September 1, 2010

Enrollment Period

7 months

First QC Date

September 30, 2010

Last Update Submit

July 25, 2011

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusHbA1cGlycation RateFructosamine

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint is to see whether they are fast glycators

    One Week

Secondary Outcomes (1)

  • A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours

    One Week

Study Arms (2)

Fast Glycator

ACTIVE COMPARATOR

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

Other: Fast Glycator

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Fast GlycatorOTHER

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

Fast Glycator
ControlOTHER

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

Control

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 16371630BACKGROUND

  • 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.

    PMID: 9742976BACKGROUND

  • 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.

    PMID: 12502674BACKGROUND

  • 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.

    PMID: 12200073BACKGROUND

  • 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.

    PMID: 15161772BACKGROUND

  • 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.

    PMID: 9101100BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 1, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2011

Last Updated

July 26, 2011

Record last verified: 2010-09