Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome

Sponsor
Ping Li,MD
Study ID
NCT06256289
Phase
PHASE4
Status
Unknown

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin 100mg Tab — DRUG
    Canagliflozin 100mg once daily combined Metformin 1000mg twice daily
  • Metformin Hydrochloride — DRUG
    Metformin 1000mg twice daily

Study Details

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.

Key Dates

Start date
Mar 31, 2024
Status verified
Feb 2024
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: canagliflozin plus metformin group
    canagliflozin 100 mg once daily plus metformin 1000 mg twice daily
  • Active Comparator: metformin group
    metformin 1000 mg twice daily

Primary Outcome Measure

liver steatosis index CAP (Controlled Attenuation Parameter) measured by FibroScan [ Time Frame: at baseline and 12 weeks ]

Central Contacts

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