Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256289
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-28
Brief Title:
Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome
Sponsor:
Ping LiMD
Organization:
The First Affiliated Hospital of Shanxi Medical University
Study Overview
Official Title:
Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome Combined With Non-Alcoholic Fatty Liver Disease A Single-center Open-labeled Prospective Randomized Controlled
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CANAMET 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
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 CANAMET 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
Detailed Description:
Objective 1 This study employs the latest ultra-high performance liquid chromatography-mass spectrometry platform for metabolomics and proteomics research to analyze serum samples from patients with Polycystic Ovary Syndrome PCOS coexisting with Non-Alcoholic Fatty Liver Disease NAFLD The aim is to identify specific biomarkers for the diagnosis of PCOS combined with NAFLD At the same time this study explores the pathogenesis and potential new therapeutic targets of PCOS combined with NAFLD at the protein and metabolic levels 2 The study examines the role of Canagliflozin in improving the safety and efficacy of PCOS and NAFLD patients providing evidence for the use of SGLT2 inhibitors as an effective treatment for PCOS with NAFLD
Methods The study enrolled 50 non-diabetic PCOS women and assessed cardiovascular metabolic indicators including liver NAFLD screening risk stratification insulin resistance index etc These were compared with 50 age and BMI-matched healthy controls Utilizing the latest ultra-high performance liquid chromatography-mass spectrometry platform for metabolomics and proteomics research a diagnostic model for PCOS coexisting with NAFLD was established and evaluated The 50 patients were randomized 11 to receive CanagliflozinMetformin or Metformin treatment The CanagliflozinMetformin group received Canagliflozin 100 mg once daily plus metformin 1000 mg twice daily and the metformin group received Metformin 1000 mg twice daily for a continuous period of three months The study assessed the safety and efficacy of PCOS and NAFLD patients
Methods The study enrolled 50 non-diabetic PCOS women and assessed cardiovascular metabolic indicators including liver NAFLD screening risk stratification insulin resistance index etc These were compared with 50 age and BMI-matched healthy controls Utilizing the latest ultra-high performance liquid chromatography-mass spectrometry platform for metabolomics and proteomics research a diagnostic model for PCOS coexisting with NAFLD was established and evaluated The 50 patients were randomized 11 to receive CanagliflozinMetformin or Metformin treatment The CanagliflozinMetformin group received Canagliflozin 100 mg once daily plus metformin 1000 mg twice daily and the metformin group received Metformin 1000 mg twice daily for a continuous period of three months The study assessed the safety and efficacy of PCOS and NAFLD patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None