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%,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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