Diabetes Mellitus, Type 2NCT02117154
Relationship Between HbA1c, Fasting Plasma Glucose, Post-prandial Glucose and Other Measures of Glycemic Control
An observational study of Diabetes Mellitus, Type 2, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study aims to evaluate relative contributions of fasting plasma glucose and postprandial glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship between HbA1c, CGM, serum fructosamine and eAG, will also be looked into. HYPOTHESES: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 6-day Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- Jun 2013to Sep 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from Diabetes Clinic, University of Malaya Medical Center
Who may be able to join
- Age ≥ 18 years old
- Diagnosed with T2DM with stable HbA1c
- On OAD, insulin or combination therapy for a minimum of 3 months
- HbA1c ≥ 6%
- Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min
- Normal haemoglobin level Male: 13.0 - 18.0 g/dL Female: 11.5 - 16.5 g/dL Mean corpuscular volume (MCV): 77 - 95 femtoliters (fL) Mean corpuscular hemoglobin (MCH): 27 - 32 pg Mean corpuscular hemoglobin concentration (MCHC): 32 - 36 g/dL
Who cannot join
- Newly diagnosed T2DM (<3 months)
- T1DM patients
- Not on OAD or insulin therapy
- Hospitalized patients
- Patients with other co-morbidities, eg chronic liver disease, advanced cardiac disease, malignancy, on steroid therapy
- eGFR< 60ml /min
Show all 12Show fewer
- Patients with anaemia
- Known haemoglobinopathies, eg alpha and beta thalassemia, sickle cell disease, Hemoglobin-E thalassemia etc
- Patients with history of blood transfusion in the preceding three months
- Patients who are likely to receive or donate blood / blood products during the study period
- Patients who are on erythropoietin therapy
- Patients who are pregnant or plan for pregnancy
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University of Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: Relationship Between HbA1c, Fasting Plasma Glucose, Post-prandial Glucose and Other Measures of Glycemic Control in Malaysian Type 2 Diabetes Mellitus Patients
This study aims to evaluate relative contributions of fasting plasma glucose and postprandial glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship between HbA1c, CGM, serum fructosamine and eAG, will also be looked into.
HYPOTHESES:
- Fasting hyperglycaemia is the main contributor in Malaysian T2DM patients with poor glycaemic control (high HbA1c), postprandial hyperglycaemia plays a more important role with lower HbA1c levels.
- There is good correlation between HbA1c, CGM, serum fructosamine and eAG in Malaysian patients.
Read the detailed description
Glycated haemoglobin (HbA1c) is formed via a non-enzymatic glycation pathway by the exposure of haemoglobin to plasma glucose. The HbA1c assay is widely used to assess glycaemic control in diabetes mellitus (DM) over a 60 to 90 day period and has been shown to correlate with the development of complications in both Type 1 (T1DM) and Type 2 diabetes mellitus (T2DM).
(A) HbA1c, Fasting Plasma Glucose and Post-prandial Glucose
Several studies have looked at the relationship between fasting glucose, post-prandial glucose and HbA1c, yielding conflicting results.
In 2001, one study examined the relationships between plasma glucose and HbA1c in 371 T2DM patients who were on lifestyle modification or oral antidiabetic drugs (OADs). These patients performed self monitoring of blood glucose (SMBG) 5 to 6 times per day (fasting, pre-meal and 2 hours post-prandial). In this study HbA1c had better correlation with pre-prandial glucose rather than postprandial hyperglycaemia.
A landmark study was carried out in 2003 using one-day, 4-point, SMBG profiles in 290 T2DM patients who were on oral anti-diabetic drugs (OAD) but not on insulin. This study suggested that in patients with HbA1c < 8.5%, post-prandial hyperglycaemia was the main contributor to excessive glucose levels. Conversely, in patients with HbA1c levels ≥ 8.5%, fasting hyperglycaemia predominated. This pattern has been proposed to reflect the natural progression of T2DM, with post-prandial hyperglycaemia occurring earlier in the course of T2DM and fasting hyperglycaemia gradually predominating with progressive β-cell failure.
This concept was challenged later, where 7-point SMBG profiles at baseline and after 24 weeks were performed in 1699 patients with T2DM (on OAD or insulin therapy) with HbA1c ˃ 7%. It found that fasting hyperglycaemia was the main contributor to overall hyperglycaemia (76-80%) from the lowest to highest HbA1c levels.
Another similar study was carried out in Taiwan in 2010 (Asian descent), with several key differences. This is important as Asian T2DM patients have been shown to have a predominantly insulin secretory defect as opposed to the insulin resistance which typifies T2DM in Caucasians. Different ethnic populations have also been shown to glycate haemoglobin at different rates. HbA1c is consistently higher in African Americans compared to non-Hispanic White, no matter if normal glucose tolerance (by 0.13-0.21%), pre-diabetes (by 0.26-0.30%) or diabetes (by 0.47%). Another key difference in the taiwanese study was the use of continuous glucose monitoring (CGM) over a 3 day period in 121 T2DM patients treated with OAD, which provided a far greater number of measured glucose values compared to SMBG. It found that post-prandial hyperglycaemia contributed significantly (80%) to overall hyperglycaemia when HbA1c was < 7%. At levels of HbA1c > 7%, the study reported that both fasting and post-prandial glucose levels made equal contributions to the overall glycaemic status.
(B) HbA1c, serum fructosamine and estimated average glucose (eAG)
Although HbA1c is regarded as the gold standard in the assessment of overall glycaemic status in diabetes mellitus, there are several limitations to its use. Factors affecting erythrocyte turnover, such as haemoglobinopathies (which are more prevalent in Asians), chronic renal failure, recent blood transfusion and erythropoietin therapy may render HbA1c unsuitable for assessing glycaemic status. In such instances, other methods for assessing glycaemic control may be used.
Fructosamine is formed when plasma glucose reacts with protein. Serum fructosamine levels have been used to indicate average glucose levels over a 2 to 3 week period. The correlation between serum fructosamine and HbA1c levels has been described in Caucasians but not in an Asian population12. It was reported that there was discordance between HbA1c and fructosamine, especially in the presence of nephropathy.
SMBG and CGM are alternatives to HbA1c in assessing chronic glycaemia. The A1c-derived Average Glucose (ADAG) study looked at 700 individuals (300 T1DM, 300 T2DM and 100 healthy individuals). HbA1c, 8-point SMBG and 48-hour CGM were assessed monthly over a 4 month period. Glucose levels accrued from SMBG and CGM were used to calculate estimated average glucose levels (eAG).The ADAG study identified a linear relationship between HbA1c and eAG over the preceding 8-12 weeks for both T1DM and T2DM patients with normal erythrocyte lifespan. One of the limitations of the ADAG study was the under-representation of Asians subjects.
By performing our study, we aim to evaluate the glycaemic profiles of T2DM patients over a wide spectrum of HbA1c, by using 6 day CGM, from Asian perspectives. We also hope to establish positive correlation among HbA1c, serum fructosamine, estimated average glucose and CGM in this group of population.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 6-day Continuous Glucose Monitoring System
- Keywords
- Continuous Glucose Monitoring System, HbA1c, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-day Continuous Glucose Monitoring SystemDevice
Also called Medtronic iPro2 Professional CGM
performed 3 times on a patient, one month apart
| Study group | Role | What they receive |
|---|---|---|
| HbA1c, 6-day Professional CGM | 6-day Continuous Glucose Monitoring System (Medtronic iPro2 Professional CGM) will be deployed on a same patient for 3 times, which is one month apart Receives: Device: 6-day Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under The Curve for Glucose excursion
Measured: Measurement on total 24hours, total postprandial period in 24 hours and 4 hours postprandial period for each meal
Secondary outcomes (1)
Measurement of HbA1c, fructosamine, Glycated albumin levels
Measured: Each test is repeated 3 times on monthly basis, ie month 0,1 and 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ALEXANDER TONG BOON TAN, MRCP (UK), Principal investigator, University of Malaya Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117154
- Sponsor's protocol ID
- MEC 988.5
- Status last verified
- Oct 2014
- First submitted
- 5 Apr 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between HbA1c, Fasting Plasma Glucose, Post-prandial Glucose and Other Measures of Glycemic Control in Malaysian Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT02117154
- Acronym / sponsor ID
- MEC 988.5
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Continuous Glucose Monitoring System, HbA1c, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Apr 2014 (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 study aims to evaluate relative contributions of fasting plasma glucose and postprandial glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship between HbA1c, CGM, serum fructosamine and eAG, will also be looked into.
HYPOTHESES:
- Fasting hyperglycaemia is the main contributor in Malaysian T2DM patients with poor glycaemic control (high HbA1c), postprandial hyperglycaemia plays a more important role with lower HbA1c levels.
- There is good correlation between HbA1c, CGM, serum fructosamine and eAG in Malaysian patients.
Detailed description
Glycated haemoglobin (HbA1c) is formed via a non-enzymatic glycation pathway by the exposure of haemoglobin to plasma glucose. The HbA1c assay is widely used to assess glycaemic control in diabetes mellitus (DM) over a 60 to 90 day period and has been shown to correlate with the development of complications in both Type 1 (T1DM) and Type 2 diabetes mellitus (T2DM).
(A) HbA1c, Fasting Plasma Glucose and Post-prandial Glucose
Several studies have looked at the relationship between fasting glucose, post-prandial glucose and HbA1c, yielding conflicting results.
In 2001, one study examined the relationships between plasma glucose and HbA1c in 371 T2DM patients who were on lifestyle modification or oral antidiabetic drugs (OADs). These patients performed self monitoring of blood glucose (SMBG) 5 to 6 times per day (fasting, pre-meal and 2 hours post-prandial). In this study HbA1c had better correlation with pre-prandial glucose rather than postprandial hyperglycaemia.
A landmark study was carried out in 2003 using one-day, 4-point, SMBG profiles in 290 T2DM patients who were on oral anti-diabetic drugs (OAD) but not on insulin. This study suggested that in patients with HbA1c < 8.5%, post-prandial hyperglycaemia was the main contributor to excessive glucose levels. Conversely, in patients with HbA1c levels ≥ 8.5%, fasting hyperglycaemia predominated. This pattern has been proposed to reflect the natural progression of T2DM, with post-prandial hyperglycaemia occurring earlier in the course of T2DM and fasting hyperglycaemia gradually predominating with progressive β-cell failure.
This concept was challenged later, where 7-point SMBG profiles at baseline and after 24 weeks were performed in 1699 patients with T2DM (on OAD or insulin therapy) with HbA1c ˃ 7%. It found that fasting hyperglycaemia was the main contributor to overall hyperglycaemia (76-80%) from the lowest to highest HbA1c levels.
Another similar study was carried out in Taiwan in 2010 (Asian descent), with several key differences. This is important as Asian T2DM patients have been shown to have a predominantly insulin secretory defect as opposed to the insulin resistance which typifies T2DM in Caucasians. Different ethnic populations have also been shown to glycate haemoglobin at different rates. HbA1c is consistently higher in African Americans compared to non-Hispanic White, no matter if normal glucose tolerance (by 0.13-0.21%), pre-diabetes (by 0.26-0.30%) or diabetes (by 0.47%). Another key difference in the taiwanese study was the use of continuous glucose monitoring (CGM) over a 3 day period in 121 T2DM patients treated with OAD, which provided a far greater number of measured glucose values compared to SMBG. It found that post-prandial hyperglycaemia contributed significantly (80%) to overall hyperglycaemia when HbA1c was < 7%. At levels of HbA1c > 7%, the study reported that both fasting and post-prandial glucose levels made equal contributions to the overall glycaemic status.
(B) HbA1c, serum fructosamine and estimated average glucose (eAG)
Although HbA1c is regarded as the gold standard in the assessment of overall glycaemic status in diabetes mellitus, there are several limitations to its use. Factors affecting erythrocyte turnover, such as haemoglobinopathies (which are more prevalent in Asians), chronic renal failure, recent blood transfusion and erythropoietin therapy may render HbA1c unsuitable for assessing glycaemic status. In such instances, other methods for assessing glycaemic control may be used.
Fructosamine is formed when plasma glucose reacts with protein. Serum fructosamine levels have been used to indicate average glucose levels over a 2 to 3 week period. The correlation between serum fructosamine and HbA1c levels has been described in Caucasians but not in an Asian population12. It was reported that there was discordance between HbA1c and fructosamine, especially in the presence of nephropathy.
SMBG and CGM are alternatives to HbA1c in assessing chronic glycaemia. The A1c-derived Average Glucose (ADAG) study looked at 700 individuals (300 T1DM, 300 T2DM and 100 healthy individuals). HbA1c, 8-point SMBG and 48-hour CGM were assessed monthly over a 4 month period. Glucose levels accrued from SMBG and CGM were used to calculate estimated average glucose levels (eAG).The ADAG study identified a linear relationship between HbA1c and eAG over the preceding 8-12 weeks for both T1DM and T2DM patients with normal erythrocyte lifespan. One of the limitations of the ADAG study was the under-representation of Asians subjects.
By performing our study, we aim to evaluate the glycaemic profiles of T2DM patients over a wide spectrum of HbA1c, by using 6 day CGM, from Asian perspectives. We also hope to establish positive correlation among HbA1c, serum fructosamine, estimated average glucose and CGM in this group of population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HbA1c, 6-day Professional CGM | – | Device: 6-day Continuous Glucose Monitoring System6-day Continuous Glucose Monitoring System (Medtronic iPro2 Professional CGM) will be deployed on a same patient for 3 times, which is one month apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from Diabetes Clinic, University of Malaya Medical Center
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Diagnosed with T2DM with stable HbA1c
- On OAD, insulin or combination therapy for a minimum of 3 months
- HbA1c ≥ 6%
- Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min
Key exclusion criteria (12 listed)
- Newly diagnosed T2DM (<3 months)
- T1DM patients
- Not on OAD or insulin therapy
- Hospitalized patients
- Patients with other co-morbidities, eg chronic liver disease, advanced cardiac disease, malignancy, on steroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-day Continuous Glucose Monitoring SystemAlso: Medtronic iPro2 Professional CGMperformed 3 times on a patient, one month apart | Device | HbA1c, 6-day Professional CGM |
Primary outcome
Area Under The Curve for Glucose excursion
Time frame: Measurement on total 24hours, total postprandial period in 24 hours and 4 hours postprandial period for each meal
1 secondary outcome
Measurement of HbA1c, fructosamine, Glycated albumin levels
Time frame: Each test is repeated 3 times on monthly basis, ie month 0,1 and 2.
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 22 Oct 2014.
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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.
ALEXANDER TONG BOON TAN, MRCP (UK) principal investigator
University of Malaya Medical Center
1 site 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, Type 2, run by University of Malaya at 1 site in Malaysia.
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 6 inclusion and 12 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 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
Area Under The Curve for Glucose excursion (time frame: Measurement on total 24hours, total postprandial period in 24 hours and 4 hours postprandial period for each meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2014.