Inositol Supplementation to Treat Reproductive and Metabolic Dysfunction in Polycystic Ovary Syndrome: A Double Blind RCT (INSUPP-PCOS)

PROJECT SUMMARY ABSTRACT Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women. It is a heterogeneous syndrome with reproductive dysfunction of chronic anovulation and hyperandrogenism, as well as metabolic dysfunction: insulin resistance, glucose intolerance and metabolic syndrome. One such medication that may improve both aspects of PCOS is inositol and it is available throughout the world as a dietary supplement. More specifically we will study a combination of isomers, d-chiro and myo-inositol. The combination is thought to improve insulin (and gonadotropin) signaling by restoring an imbalance in inositolglycans which are second messengers in cell surface signaling. This project is the first adequately powered and designed double-blind randomized clinical trial to test prospectively the effects of inositol supplementation in a double blind study (the INSUPP PCOS study). We are conducting a four-armed study of inositol: Inositol at 1 gm, 2 gm, 3 gm bid vs. placebo bid over a 3 month period in 108 women with PCOS. The purpose of this supplement is for us to complete the total enrollment count of 108 women. We want to successfully complete this project in order to reach our study goals and specific aims, which remain the same. Identify the effect of inositol supplementation on serum testosterone levels during the study. Hypothesis 1 (Primary Outcome): Women with PCOS who receive inositol supplementation will have a significantly greater reduction in serum total testosterone than women on placebo, as well as our secondary markers of hyperandrogenism: SHBG and the free androgen index.