HbA1c and Metabolic Biomarker Analysis

Type 2 Diabetes and HbA1c in Clinical Research

Diabetes is a chronic metabolic disorder characterised by persistently elevated blood glucose levels. Type 2 diabetes is the most common form and develops when the body becomes less responsive to insulin and is no longer able to regulate blood glucose effectively.

Vitas provides quantitative analysis of HbA1c in liquid whole blood, red blood cells and dried blood spot (DBS) samples for professionally sponsored clinical studies, population research, intervention studies and other contract analytical projects.

Vitas also offers analysis of additional biomarkers relevant to diabetes and metabolic research, including C-peptide, triglycerides and appetite-related hormones such as PYY, CCK, ghrelin, leptin and GLP-1.

Type 1 and Type 2 Diabetes

There are two main forms of diabetes.

Type 1 diabetes is an autoimmune disease in which the immune system damages the insulin-producing beta cells in the pancreas. It often develops during childhood or adolescence, although it may occur at any age.

Type 2 diabetes is characterised by insulin resistance and, over time, insufficient insulin production. It accounts for the majority of diabetes cases worldwide. Important risk factors include overweight, obesity, physical inactivity, age, genetic predisposition and family history.

Diabetes is associated with an increased risk of cardiovascular disease, kidney disease, impaired vision, neuropathy and reduced peripheral circulation.

Management of type 2 diabetes may include dietary changes, increased physical activity, weight reduction and medication. The appropriate approach depends on the individual and should be determined in consultation with qualified healthcare professionals.

HbA1c

HbA1c, or glycated haemoglobin, is formed when glucose binds to haemoglobin in red blood cells.

Because red blood cells circulate for several months, HbA1c reflects average blood glucose exposure over approximately the previous two to three months.

This makes HbA1c useful in clinical research and professionally managed healthcare settings where long-term glucose regulation is being studied or monitored.

Figure 1

Glucose reacts with haemoglobin to form glycated haemoglobin. Higher average blood glucose concentrations generally result in higher HbA1c concentrations.

Analytical use of HbA1c

HbA1c can be measured in several biological matrices, including:

• venous whole blood;

• isolated red blood cells;

• dried blood spots.

The suitability of the matrix and analytical method depends on the study design, intended purpose, sample handling, validation requirements and reporting needs.

HbA1c has several practical advantages as a research biomarker:

• fasting is generally not required;

• it reflects longer-term glucose exposure;

• it is less affected by short-term fluctuations than a single glucose measurement;

• it is suitable for longitudinal and population-based studies.

Interpretation of HbA1c results may be affected by factors such as altered red blood cell turnover, haemoglobin variants, anaemia, kidney disease, recent blood loss or transfusion. These factors should be considered in the design and interpretation of clinical and research projects.

Vitas HbA1c analytical services

Vitas performs quantitative HbA1c analysis for professional customers, including pharmaceutical and biotechnology companies, universities, hospitals, research institutions and other project sponsors.

Our services may support:

• clinical and observational studies;

• population and epidemiological research;

• nutritional and lifestyle interventions;

• metabolic research;

• pharmaceutical development;

• method-development and validation projects.

Vitas has high-throughput capabilities for the analysis of large sample sets. The analytical method, validation level, sample requirements, quality controls and reporting format are agreed individually for each project.

The project sponsor or customer defines the intended purpose, regulatory framework and any clinical interpretation associated with the project. Vitas is responsible for the analytical quality and performance of the laboratory services it provides.

Additional biomarkers for diabetes and metabolic research

In addition to HbA1c, Vitas offers analysis of biomarkers that may be relevant in metabolic and diabetes-related studies, including:

• C-peptide;

• triglycerides;

• PYY;

• CCK;

• ghrelin;

• leptin;

• GLP-1.

The choice of biomarkers depends on the scientific objectives and design of the individual project.

Contact

For information about HbA1c analysis, DBS sampling, method development or a diabetes-related research project, please contact:

Thomas E. Gundersen
teg@vitas.no

Further reading

• World Health Organization. Diabetes.

• World Health Organization. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus. 2011.

• Juda TM et al. Polymorphism of aldose reductase gene and susceptibility for developing diabetic retinopathy among type 2 diabetes mellitus patients. J Babylon Univ/Pure Appl Sciences. 2016;24(5):1469–1484.