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Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome

NCT06256289 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-13

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome
  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Canagliflozin 100mg Tab

Canagliflozin 100mg once daily combined Metformin 1000mg twice daily

DRUG

Metformin Hydrochloride

Metformin 1000mg twice daily

Sponsors & Collaborators

  • Ping Li,MD

    lead OTHER

Principal Investigators

  • Ping Li, MD · The First Affiliated Hospital of Shanxi Medical University

  • Linxin Xu, MD · The First Affiliated Hospital of Shanxi Medical University

  • Yan Wang · The First Affiliated Hospital of Shanxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-04-30
Completion
2025-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06256289 on ClinicalTrials.gov