Insulin signal peptide, a novel measure of pancreatic insulin synthesis and production

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The purpose of this study is to quantify Insulin signal peptide ( INSsp) levels and the ratio of insulin to INSsp (and other pertinent biochemical, demographic and metabolic parameters) in blood taken from healthy volunteers and four patient groups commonly assessed for blood insulin/glucose relationships. We will measure the blood insulin to insulin signal peptide (INSsp) ratio to provide a measure of pancreatic beta cell function and status that cannot be obtained from insulin measurement alone. 5 groups of patients will be studied. 1. 100 normal, healthy volunteers (50 men, 50 woman) aged between 20-70 2. 70 female patients referred for glucose load testing in the first trimester of pregnancy. 3. 50 patients with polycystic ovary syndrome (PCOS) 4. 50 patients identified from the population as at risk of having T2DM (pre-diabetes) 5. 50 patients each with diagnosed T1DM and T2DM Blood from all five patient groups will be collected. Individual age, gender, height, weight, blood pressure and personal history will be recorded. Routine biochemical analyses will be performed by Canterbury Health Laboratories, Christchurch. A further 30ml fasting blood will be collected to provide for plasma storage banking at the Christchurch Heart Institute laboratory. All patients will be followed up at one and two years after recruitment to ascertain development of diabetes and/or review metabolic parameters. Follow up visits will include repeat demographic measurements, review of medical notes/records to determine diabetic status as well as blood measurements of fasting glucose, insulin, INSsp, C-peptide and Hba1c.

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