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canagliflozin 100 mg once daily plus metformin 1000 mg twice daily

Canagliflozin 100mg once daily combined Metformin 1000mg twice daily

Canagliflozin 100mg Tab

Metformin Hydrochloride

Ping Li, MD

Linxin Xu, MD

Yan Wang

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.

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 1:1 to receive Canagliflozin/Metformin or Metformin treatment. The Canagliflozin/Metformin 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.

Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome

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

Changes in the liver steatosis index CAP (Controlled Attenuation Parameter) as measured by transient elastography after 12 weeks of treatment.

Changes in the liver stiffness index (LS) (measured by transient elastography) from baseline to 12 weeks of treatment.

Changes in Body Composition，including total body water, muscle mass, fat mass (subcutaneous and visceral), fat-free mass detected using Bioelectrical Impedance Analysis (BIA) from baseline to 12 weeks of treatment.

Changes in proteomics markers from baseline to 12 weeks of treatment, involving systematic quantification of metabolites and proteins using techniques LC-MS for analysis, with chemometric methods for data interpretation, revealing metabolic pathways and biomarkers.

Changes in metabolomics markers from baseline to 12 weeks of treatment, including phosphatidylglycerol (PG), Bis(monoacylglycero)phosphate BMP, Sulfatide (sulfatide) (SL), Free fatty acids FFA, Plasmalogen ethanolamine (PE-O), Phosphatidylethanolamine (PE), Phosphatidylinositol (PI), Phosphatidylserine (PS), Monosialosyl ganglioside (GM3) plasmalogen (PCO), Phosphatidylcholine (PC), Lysophosphatidic acid (PA), Lysophosphatidylethanolamine (LPE), Lysophosphatidic acid (LPA), Lysophosphatidylinositol (LPI), Lysophosphatidylserine (LPS), Ceramide(Cer), Lysophosphatidylcholine （LPC), Plasmalogen choline (PCO), Phosphatidylcholine (PC),Sphingomyelin (SM),Sphingosine (Sph）,Ceramide（Cer）,Hexosylceramide （HexCer）, Lactosylceramide （LacCer）, Trihexosylceramide （Gb3), Acylcarnitine acylcarnitine, Monoacylglycerol (MAG), Diglyceride (DAG), Triglyceride (TAG), Cholesteryl ester (CE)

Changes in sex hormones by liquid chromatography-tandem mass spectrometry (LC-MS/MS) mass spectrometry from baseline to 12 weeks of treatment, including estriol, hydrocortisone, cortisone, corticosterone, aldosterone, testosterone, 17a-Hydroxyprogesterone, 21-hydroxyprogesterone, DHEA,Estrone, androstenedione, dihydrotestosterone, estradiol,progesterone, pregnenolone, androsterone, epitestosterone, estrone sulfate, estradiol sulfate, epitestosterone sulfate, testosterone sulfate, dhea Sulfate, pregnenolone Monosulfate

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Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome	NCT06256289	Polycystic Ovar... Non-Alcoholic F...	Canagliflozin 1... Metformin Hydro...	18 Years - 45 Years	The First Affiliated Hospital of Shanxi Medical University
Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome	NCT06256289	Polycystic Ovar... Non-Alcoholic F...	Canagliflozin 1... Metformin Hydro...	18 Years - 45 Years	The First Affiliated Hospital of Shanxi Medical University

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