Investigating the Insulin Sensitizing Effects of Metformin and Myo-Inositol in Polycystic Ovary Syndrome: A Randomized Controlled Trial Protocol

Abstract

Introduction: Polycystic ovary syndrome (PCOS) is an endocrine disorder characterized by ovulatory dysfunction, hyperandrogenism, and metabolic dysregulation. Insulin resistance (IR) is a common hallmark of PCOS and contributes to metabolic dysfunction. A combination of lifestyle changes and symptom management treatments can help manage the condition. Metformin and myo-inositol (MI) have been shown to improve insulin sensitivity and reduce excess androgen levels in women with PCOS, but there is a lack of research on the effects of combinatory therapy of MI and metformin. This study aims to investigate the hypothesis that a combination of MI and metformin will result in improved insulin sensitivity and clinical outcomes of PCOS. Methods: The study is a double-blinded, randomized controlled trial examining 60 women diagnosed with PCOS that demonstrate the presence of IR. Participants are randomized to one of the following treatments over a six-month period: metformin (MET), inositol (INO), combined metformin and inositol (MET-INO) or placebo-control (CON). BMI, LH:FSH ratio, and the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) were assessed at day 0, day 84 and day 168. Anticipated Results: It is anticipated that the MET-INO group will have the most profound effects following intervention, with a decrease in BMI by 3-4%, a decrease in LH:FSH ratio by 30-40%, and a decrease in HOMA-IR by 1-1.5. MET group is expected to have a significant decrease in BMI by 2-3%, a decrease in LH:FSH ratio by 20-30%, and a decrease in HOMA-IR by 0.5-1.5. The INO group is anticipated to experience a significant decrease in BMI by 1-2%, a decrease in LH:FSH ratio by 10-20%, and a decrease in HOMA-IR by 0.2-0.4. Conclusion: The findings of this study suggest that a combination therapy of metformin and MI may offer a more effective treatment option for improving insulin sensitivity in women with PCOS, compared to metformin or inositol treatment alone. These results have important implications for patients with PCOS and clinicians managing their care. Future studies should further investigate the effectiveness and long-term effects of these treatments.