Overview

Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome

Status:
NOT_YET_RECRUITING
Trial end date:
2025-04-30
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to investigate the use of ultra-high performance liquid chromatography-mass spectrometry for metabolomics and proteomics research in patients with Polycystic Ovary Syndrome (PCOS) and Non-Alcoholic Fatty Liver Disease (NAFLD). The main questions it aims to answer are: * How can this technology help identify specific biomarkers for diagnosing PCOS combined with NAFLD? * What is the role of Canagliflozin in improving the safety and efficacy of treatment for PCOS and NAFLD patients? Participants, who are 50 non-diabetic women with PCOS, will undergo a series of assessments including cardiovascular metabolic indicators, liver NAFLD screening risk stratification, and insulin resistance index. They will be compared with 50 age and BMI-matched healthy controls. The participants will be randomized to receive either CANA/MET (Canagliflozin 100 mg daily plus Metformin 1000 mg twice daily) or MET (Metformin 1000 mg twice daily) for a continuous period of three months. The study will evaluate various parameters including menstrual patterns, anthropometric parameters, gonadal parameters, glucose-lipid homeostasis, liver enzyme indices, non-invasive hepatic fat changes, metabolomics, and NAFLD-related indicators.
Phase:
PHASE4
Details
Lead Sponsor:
Ping Li,MD
Treatments:
Canagliflozin
Metformin