Relationship Between HbA1c, Fasting Plasma Glucose, Post-prandial Glucose and Other Measures of Glycemic Control in Malaysian Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Area Under The Curve for Glucose excursion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Area Under The Curve for Glucose excursion
时间窗: Measurement on total 24hours, total postprandial period in 24 hours and 4 hours postprandial period for each meal
次要结局
- Measurement of HbA1c, fructosamine, Glycated albumin levels(Each test is repeated 3 times on monthly basis, ie month 0,1 and 2.)