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Can HbA1c Replace OGTT for the Diagnosis of Diabetes Mellitus Among Chinese Patients With IFG?

NCT02439684 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1357

Last updated 2016-03-07

No results posted yet for this study

Summary

This is a cross-sectional study that aims to assess the sensitivity and specificity of using HbA1c as a diagnostic test for detecting the presence of diabetes mellitus (DM) when compared to the use of oral glucose tolerance test (OGTT) among Hong Kong Chinese adult who have impaired fasting glucose (IFG).

The investigators will recruit around 1000 non-diabetic adult participants who have impaired fasting glucose (i.e. fasting glucose level between 5.6 to 6.9mmol/L) AND without symptoms of hyperglycaemia to undergo both HbA1c test and oral glucose tolerance test after obtaining their informed consent. A diagnosis of DM is confirmed when both the fasting glucose level and 2-hour-post challenge plasma glucose level fall into diabetic range (i.e. fasting glucose level ≥7.0mmol/L and 2-hour-post challenge plasma glucose level ≥11.1mmol/L) after a standard 75g OGTT. Participants with only 1 plasma glucose value within the diabetic range will be invited to repeat an oral glucose tolerance test for confirmation of their diagnosis as recommended by American Diabetes Association and World Health Organization. Demographic data of the participants including age, gender, smoking status, medical history, diet and activity level will be collected. Lipid profile, blood pressure, waist circumference and body mass index will be checked and the total cardiovascular risk in 10 years will be calculated for each participant using the Joint British Societies 2005 and Framingham 2008 equations to evaluate the baseline cardiovascular risk of the participants.

These data will be analyzed using SPSS. The primary outcomes are the sensitivity and specificity of HbA1c in detecting diabetes mellitus diagnosed by oral glucose tolerance test (the gold standard). A receiver operating characteristic (ROC) curve will be obtained by plotting sensitivity against (1-specificity) for each cutoff value for identification of an optimal cutoff point. Diagnostic accuracy will be assessed by the area under the curve (AUC). The differences in characteristics among participants diagnosed to have diabetes mellitus by oral glucose tolerance test or HbA1c will be compared using independent t-test or χ2 test for comparison between the 2 groups.

Conditions

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • YU YT Esther, Doctor · Department of Family Medicine and Primary Care, The University of Hong Kong

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439684 on ClinicalTrials.gov