Short-term and low-dose liraglutide plus metformin decreased body mass index and insulin resistance more than metformin alone in obese women with polycystic ovary syndrome: An open-label randomized controlled study

Abstract

Background and objectives: Reduction of weight improves different manifestations of polycystic ovary syndrome (PCOS). This study compared the effects of liraglutide plus metformin versus metformin alone on weight loss and metabolic profiles in obese women with PCOS. Methods: This open-label randomized controlled clinical trial consecutively recruited newly-diagnosed PCOS patients of reproductive age with obesity (body mass index ≥ 27.5 kg/m2). Following randomization into two equal groups, Group-1 received treatment with metformin 1000 mg daily alone while Group-2 was given metformin 1000 mg plus subcutaneous (SC) liraglutide 1.2 mg daily for 12 weeks. Anthropometric, biochemical and hormonal data and ovarian morphology were assessed at baseline and after 12 weeks. Clinical information and side effects were recorded every four weeks after initiation of the treatment. Glucose, lipids, and all hormones were analyzed by glucose oxidase, precipitation method, and chemiluminescent microparticle immunoassay respectively. Insulin resistance was measured by homeostatic model assessment (HOMA-IR). Results: Study included 30 participants comprising 15 for each group. Among 15 participants, 5 dropped out from the Group-1 and 1 dropped out from the Group-2. The final analysis was done among 24 participants (Gr-1: 10 and Gr-2: 14). Waist and hip circumference (WC, HC) significantly (p <0.05) decreased in patients treated with only metformin. Menstrual irregularity, BMI (body mass index), HC, systolic blood pressure (BP), 2h-OGTT glucose, fasting insulin, and HOMA-IR significantly (p < 0.05) decreased in the patients of Group-2 after 12 weeks compared to baseline status. Percentage changes of weight, BMI and HOMA-IR improved significantly (p < 0.05) in cases of Group-2 than those in Group-1. Side effects were though numerically higher in the Group-2 patients, but reduced with time. Conclusions: Addition of liraglutide with metformin was superior to metformin alone for lowering of BMI and insulin resistance among obese PCOS women with acceptable side effects. IMC J Med Sci. 2024; 18(1):002. DOI: https://doi.org/10.55010/imcjms.18.002 *Correspondence: Muhammad Abul Hasanat, Room# 1524, Level-15, Block-D, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka-1000, Bangladesh. ORCID iD: orcid.org/0000-0001-8151-9792; Email: [email protected]