Type 2 diabetes affects up to 12 % and insulin resistance up to 42 % of the population in industrialized countries. They represent the major risk factors of cardiovascular morbidity and mortality and are therefore a major public health issue. Numerous studies indicate that early treatment of insulin resistance strongly reduces the progression of the disease towards diabetes as well as the occurrence of cardiovascular diseases. To date the diagnosis of insulin resistance is based on the determination of glycemia, together or not with insulinemia at one or several time points during two hours after oral administration of glucose (OGTT). This test is tedious, not very reproducible and does not directly measure the sensitivity of the organism to insulin. Moreover, there is a lack of correlation between these tests and changes in insulin sensitivity over time.
We developed a simple new blood test for the screening and early diagnosis of insulin resistance and type 2 diabetes. This assay is based on the quantitative determination of the secreted domain of IRAP (Insulin Regulated Amino Peptidase) in serum. IRAP is a protein involved in the translocation of the glucose transporter GLUT4 to the plasma membrane where it allows insulin dependent glucose uptake.
– The diabetes diagnostics market is currently mainly driven by blood sugar monitoring devices. It has been estimated to reach 32 billion USD by 2017 (Strategyr).
– One of the major challenges remains the screening for diabetes and the early detection of IR none of which is currently achieved by blood sugar, HbA1c or insulin monitoring.
– Screening for IR will allow the enforcement of preventive measures aimed at preventing the onset of type 2 diabetes whose cost exceeds 250 billion $ in the US alone
– Similarly early diagnosis of type 2 diabetes will reduce co-morbidities and thereby its socio-economical cost.
– Sandwich ELISA. Detection limit 10,000-fold < serum concentration of healthy subjects.
– Pilot clinical studies indicate that:
– concentrations of IRAPs are highly correlated to glycemia and insulinemia in healthy subjects but not in diabetic patients
– In severely obese patients, IRAPs levels are significantly lower in diabetic than non-diabetic patients.
– IRAPs levels increase after bariatric surgery in severely obese patients
– An extensive clinical validation program is currently being performed in metabolic syndrome, type 2 and gestational diabetes.
Detection of insulin resistance in metabolic disorders (obesity, metabolic syndrome, diabetes, PCOS) and associated cardiovascular disease (hypertension, atherosclerosis) as well as in pregnancy.