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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Malaysia

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:

  1. 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.
  2. 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.

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 groups in NCT02117154
Study groupRoleWhat they receive
HbA1c, 6-day Professional CGM6-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.

  1. 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)
  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.

  1. First posted17 Apr 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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)
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

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.

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