Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
NCT ID: NCT07380841 Phase: NA Status: COMPLETED Enrollment: 192 Completion: 2026-01-13
Conditions
Polycystic Ovary Syndrome, Insulin Resistance, Metabolic Syndrome
Interventions
Metformin Hydrochloride, Myo-Inositol, Dietary Restriction, Metformin + Myo-inositol + Dietary Restriction
Summary
Polycystic ovary syndrome (PCOS) is a common condition that can cause irregular periods, excess male-type hormones, weight gain, and insulin resistance. This study will compare four commonly used approaches for PCOS management: metformin, inositol, a calorie-restricted diet, and a combination of all three.
A total of 192 women aged 18-35 years with PCOS (diagnosed using Rotterdam criteria) will be randomly assigned to one of four groups for 12 weeks: (A) metformin, (B) myo-inositol plus D-chiro-inositol, (C) calorie-restricted diet, or (D) combination therapy (metformin + inositol + diet). The study will assess changes in body weight, body mass index (BMI), waist circumference, fasting glucose, fasting insulin, insulin resistance (HOMA-IR), and menstrual regularity. Hormonal measures and safety outcomes will also be evaluated. The goal is to determine which approach provides the greatest overall metabolic and reproductive benefit in women with PCOS.
Primary Outcome
Change in insulin resistance (HOMA-IR)