Diabetes MellitusNCT02439684
Can HbA1c Replace OGTT for the Diagnosis of Diabetes Mellitus Among Chinese Patients With IFG?
An observational study of Diabetes Mellitus, run by The University of Hong Kong at 3 sites in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 1,357 participants
- Where
- 3 sitesHong Kong
- Study dates
- May 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese adult subjects who are classified to have IFG will be recruited from various GOPCs from the Hong Kong West Cluster and New Territories East Cluster.
Who may be able to join
- Aged ≥ 18 year
- Chinese ethnicity
- Diagnosis of impaired fasting glucose (i.e. FG between 5.6-6.9mmol/L) identified from latest blood test results within 18 months prior to recruitment)
Who cannot join
- Known history of diabetes mellitus or on hypoglycaemic treatment
- Having symptoms of hyperglycaemia at recruitment
- Women who are pregnant or breast-feeding at recruitment
- Patients taking glucocorticoid at recruitment
- Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
- Clinically significant anaemia at recruitment
- Severe renal impairment i.e. eGFR ≤ 30 ml/min/1.73m2
- History of blood donation or blood transfusion within 3 months prior to recruitment
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Tsan Yuk Hospital RAMP Clinic
Hong Kong, 852
Ap Lei Chau General Out-patient Clinic
Hong Kong
Lek Yuen General Out-patient Clinic
Hong Kong
About this study
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.
Read the detailed description
Objectives:
- To calculate the sensitivity and specificity of HbA1c, using different cut-off values compared to the use of OGTT as the gold standard in the diagnosis of the presence of DM among Chinese adult patients with IFG
- To identify the optimal cut-off value of HbA1c for diagnosing DM among the studied population
- To compare the prevalence of DM among Hong Kong Chinese non-diabetic adult patients with IFG using OGTT and/or HbA1c criteria as recommended by the 2010 ADA for the diagnosis of DM
- To compare the characteristics (i.e. demographics, presence of risk factors for DM and cardiovascular risk) of Hong Kong Chinese patients who are diagnosed to have DM by OGTT criterion alone, HbA1c criterion alone, or both criteria
Hypotheses:
- The prevalence of DM is higher among Chinese adult patients with IFG compared to the general population of Hong Kong. The figure was estimated to be as much as 25% from clinical observation. The overall prevalence of DM would be even higher if both OGTT and HbA1c criteria are used.
- The use of HbA1c, with the cut-off threshold of ≥ 6.5% recommended by the 2010 ADA criteria for the diagnosis of DM, will pick up at least 70% of the diabetes cases identified by OGTT among this high risk group, which is superior to its use among the Chinese general population.
- The sensitivity of using HbA1c ≥ 6.5% for the diagnosis of DM among this high risk group is superior to the use of FG ≥ 7.0mmol/L.
- The optimal cut-off threshold of HbA1c in diagnosing DM for this high risk group may not be 6.5% but lower.
- A subset of patients with impaired glucose regulation (IFG +/- IGT) will be identified as diabetic according to the HbA1c criterion alone. This group of patient may have a different cardiovascular risk profile compared to the group of patients who are diagnosed to have DM according to plasma glucose criteria alone.
Methods:
Research Design:
This is a cross-sectional diagnostic test study to be carried out at various general out-patient clinics (GOPCs) across Hong Kong.
Target population and Sampling method:
Around 1000 Chinese adult subjects who are classified to have IFG will be recruited from various GOPCs from the Hong Kong West Cluster and New Territories East Cluster. Convenience sampling will be employed.
Sample Size Calculation In this diagnostic test study, the sample size calculation was considered using the disease prevalence and test characteristics represented by the sensitivity and specificity of HbA1c to diagnose DM. The use of HbA1c is assumed to have an expected sensitivity and specificity of 80%, an approximate estimate according to previous studies, compared to OGTT for the diagnosis of DM among subjects with IFG and/or IGT. With an estimated prevalence of DM of 25% in the high risk Chinese population in Hong Kong based on epidemiological survey in the Chinese population with similar risk profiles, a sample of 204 subjects with DM and 612 subjects without DM will be recruited to obtain the lower limit of the 95% confidence interval greater than 0.7 with a probability of 0.9530. A sample of 816 will be required. To account for 20% attrition rate, a total sample of 1020 will be required, with 255 subjects with DM and 765 subjects without DM.
- Conditions
- Diabetes Mellitus
- Keywords
- HbA1c, Diagnostic accuracy, Diabetes Mellitus, Chinese, Impaired fasting glucose
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of the use of HbA1c
The sensitivity of the use of HbA1c at different cut points for diagnosing DM among Chinese adult patients with IFG compared to OGTT as the gold standard.
Measured: around 12-16 weeks after the study completed
The specificity of the use of HbA1c
The specificity of the use of HbA1c at different cut points for diagnosing DM among Chinese adult patients with IFG compared to OGTT as the gold standard.
Measured: around 12-16 weeks after the study completed
Secondary outcomes (5)
The optimal cut-off level of HbA1c
The optimal cut-off level of HbA1c for diagnosing DM among Chinese adult patients with IFG
Measured: around 12-16 weeks after the study completed
OGTT criteria in Chinese
The prevalence of DM among Chinese adult patients with IFG defined by OGTT criteria
Measured: around 12-16 weeks after the study completed
HbA1c criteria in Chinese
The prevalence of DM among Chinese adult patients with IFG defined by HbA1c criteria
Measured: around 12-16 weeks after the study completed
Cardiovascular risk
Difference in cardiovascular risk between patients who are diagnosed to have DM by HbA1c criteria compared to OGTT criteria
Measured: around 24-48 weeks after the study completed
DM risk
Difference in DM risk between patients who are diagnosed to have DM by HbA1c criteria compared to OGTT criteria
Measured: around 24-48 weeks after the study completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- YU YT Esther, Doctor, Principal investigator, Department of Family Medicine and Primary Care, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439684
- Sponsor's protocol ID
- UW 13-299
- Status last verified
- Mar 2016
- First submitted
- 23 Apr 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Guo VY, Yu EY, Wong CKh, Sit RW, Wang JH, Ho SY, Lam CL. Validation of a nomogram for predicting regression from impaired fasting glucose to normoglycaemia to facilitate clinical decision making. Fam Pract. 2016 Aug;33(4):401-7. doi: 10.1093/fampra/cmw031. Epub 2016 May 3.
PubMed 27142313Yu EY, Wong CK, Ho SY, Wong SY, Lam CL. Can HbA1c replace OGTT for the diagnosis of diabetes mellitus among Chinese patients with impaired fasting glucose? Fam Pract. 2015 Dec;32(6):631-8. doi: 10.1093/fampra/cmv077. Epub 2015 Oct 14.
PubMed 26467644
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can HbA1c Replace OGTT for the Diagnosis of Diabetes Mellitus Among Chinese Patients With IFG?
- ClinicalTrials.gov ID
- NCT02439684
- Acronym / sponsor ID
- UW 13-299
- Conditions
- Diabetes Mellitus
- Keywords
- HbA1c, Diagnostic accuracy, Diabetes Mellitus, Chinese, Impaired fasting glucose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,357 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
- To calculate the sensitivity and specificity of HbA1c, using different cut-off values compared to the use of OGTT as the gold standard in the diagnosis of the presence of DM among Chinese adult patients with IFG
- To identify the optimal cut-off value of HbA1c for diagnosing DM among the studied population
- To compare the prevalence of DM among Hong Kong Chinese non-diabetic adult patients with IFG using OGTT and/or HbA1c criteria as recommended by the 2010 ADA for the diagnosis of DM
- To compare the characteristics (i.e. demographics, presence of risk factors for DM and cardiovascular risk) of Hong Kong Chinese patients who are diagnosed to have DM by OGTT criterion alone, HbA1c criterion alone, or both criteria
Hypotheses:
- The prevalence of DM is higher among Chinese adult patients with IFG compared to the general population of Hong Kong. The figure was estimated to be as much as 25% from clinical observation. The overall prevalence of DM would be even higher if both OGTT and HbA1c criteria are used.
- The use of HbA1c, with the cut-off threshold of ≥ 6.5% recommended by the 2010 ADA criteria for the diagnosis of DM, will pick up at least 70% of the diabetes cases identified by OGTT among this high risk group, which is superior to its use among the Chinese general population.
- The sensitivity of using HbA1c ≥ 6.5% for the diagnosis of DM among this high risk group is superior to the use of FG ≥ 7.0mmol/L.
- The optimal cut-off threshold of HbA1c in diagnosing DM for this high risk group may not be 6.5% but lower.
- A subset of patients with impaired glucose regulation (IFG +/- IGT) will be identified as diabetic according to the HbA1c criterion alone. This group of patient may have a different cardiovascular risk profile compared to the group of patients who are diagnosed to have DM according to plasma glucose criteria alone.
Methods:
Research Design:
This is a cross-sectional diagnostic test study to be carried out at various general out-patient clinics (GOPCs) across Hong Kong.
Target population and Sampling method:
Around 1000 Chinese adult subjects who are classified to have IFG will be recruited from various GOPCs from the Hong Kong West Cluster and New Territories East Cluster. Convenience sampling will be employed.
Sample Size Calculation In this diagnostic test study, the sample size calculation was considered using the disease prevalence and test characteristics represented by the sensitivity and specificity of HbA1c to diagnose DM. The use of HbA1c is assumed to have an expected sensitivity and specificity of 80%, an approximate estimate according to previous studies, compared to OGTT for the diagnosis of DM among subjects with IFG and/or IGT. With an estimated prevalence of DM of 25% in the high risk Chinese population in Hong Kong based on epidemiological survey in the Chinese population with similar risk profiles, a sample of 204 subjects with DM and 612 subjects without DM will be recruited to obtain the lower limit of the 95% confidence interval greater than 0.7 with a probability of 0.9530. A sample of 816 will be required. To account for 20% attrition rate, a total sample of 1020 will be required, with 255 subjects with DM and 765 subjects without DM.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adult subjects who are classified to have IFG will be recruited from various GOPCs from the Hong Kong West Cluster and New Territories East Cluster.
Key inclusion criteria (3 listed)
- Aged ≥ 18 year
- Chinese ethnicity
- Diagnosis of impaired fasting glucose (i.e. FG between 5.6-6.9mmol/L) identified from latest blood test results within 18 months prior to recruitment)
Key exclusion criteria (8 listed)
- Known history of diabetes mellitus or on hypoglycaemic treatment
- Having symptoms of hyperglycaemia at recruitment
- Women who are pregnant or breast-feeding at recruitment
- Patients taking glucocorticoid at recruitment
- Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity of the use of HbA1c
Time frame: around 12-16 weeks after the study completed
The sensitivity of the use of HbA1c at different cut points for diagnosing DM among Chinese adult patients with IFG compared to OGTT as the gold standard.
The specificity of the use of HbA1c
Time frame: around 12-16 weeks after the study completed
The specificity of the use of HbA1c at different cut points for diagnosing DM among Chinese adult patients with IFG compared to OGTT as the gold standard.
5 secondary outcomes
The optimal cut-off level of HbA1c
Time frame: around 12-16 weeks after the study completed
OGTT criteria in Chinese
Time frame: around 12-16 weeks after the study completed
HbA1c criteria in Chinese
Time frame: around 12-16 weeks after the study completed
Cardiovascular risk
Time frame: around 24-48 weeks after the study completed
DM risk
Time frame: around 24-48 weeks after the study completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Derived from this study: PubMed 27142313Guo VY, Yu EY, Wong CKh, Sit RW, Wang JH, Ho SY, Lam CL. Validation of a nomogram for predicting regression from impaired fasting glucose to normoglycaemia to facilitate clinical decision making. Fam Pract. 2016 Aug;33(4):401-7. doi: 10.1093/fampra/cmw031. Epub 2016 May 3.
- Derived from this study: PubMed 26467644Yu EY, Wong CK, Ho SY, Wong SY, Lam CL. Can HbA1c replace OGTT for the diagnosis of diabetes mellitus among Chinese patients with impaired fasting glucose? Fam Pract. 2015 Dec;32(6):631-8. doi: 10.1093/fampra/cmv077. Epub 2015 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YU YT Esther, Doctor principal investigator
Department of Family Medicine and Primary Care, The University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by The University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of the use of HbA1c (time frame: around 12-16 weeks after the study completed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439684, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.