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Polycystic Ovary SyndromePhase 4NCT06256289

Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome

A Phase 4 study testing Canagliflozin 100mg Tab and Metformin Hydrochloride in people with Polycystic Ovary Syndrome and Non-Alcoholic Fatty Liver Disease, run by Ping Li,MD.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Canagliflozin 100mg Tab and Metformin Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
31 Mar 2024to 30 Apr 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • aged 18-45 years old;
  • Body mass index (BMI) more than 18.5 kg / m2;
  • PCOS diagnosis meets Rotterdam 2003 criteria: at least two of the following symptoms: menstrual menstruation / amenorrhea, hyperandrogenism, and / or biochemical and / or clinical signs of polycystic ovaries.
  • The serum pregnancy test was negative before enrollment.
  • Clinical diagnosis of fatty liver: the ratio of liver to kidney is greater than 1.0.
  • Can understand the procedures and methods of this clinical trial, patients voluntarily participate and sign the informed consent form, willing to comply with the trial protocol requirements and cooperate with the provision of biological samples for testing as planned.

Who cannot join

  • Less than 18 years old or more than 45 years old;
  • Patients who are pregnant, intend to become pregnant, are breastfeeding or giving birth;
  • Drug history in the past three months included oral contraceptives, sodium-dependent glucose transporters 2 inhibitors, glucagon-like peptide-1 receptor agonists, thiazolidinediones, metformin, corticosteroids or traditional Chinese medicine.
  • Endocrine disorders such as hyperprolactinemia, thyroid dysfunction and diabetes, Cushing's syndrome, 21-hydroxylase deficiency, congenital adrenal hyperplasia, androgen-secreting tumors, cervical, endometrial or breast cancer.
  • Severe liver function (alanine aminase, aspartate aminase> 3 times normal value or elevation of serum bilirubin to more than 3 times the upper limit of normal) or renal impairment (eGFR <60 ml/min/1.73m2).Severe cardiopulmonary, hematopoietic and hematopoietic insufficiency.
  • Current or past (most recent three months) participation in other studies.
Show all 11Show fewer
  • Viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, hemochromatosis, anti-trypsin defense, Wilson disease, parenteral nutrition history, use of drugs known to cause steatosis (such as valproate, amiodarone or vitamin E) or liver injury caused by drug abuse.Clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, and variceal bleeding.
  • drank more than 20g per day.
  • Women with persistent or recurrent symptomatic urinary tract infections (UTI), gastrointestinal (GI) problems, or any other condition that may compromise patient safety had strong fertility needs within six months of the study period.
  • Allergic or intolerant to the study drug, unable to continue treatment as required by the protocol, unwilling to complete the study or become pregnant.
  • History of mental illness within 2 years, including any suicidal behavior or major depression, depressive symptoms (defined as Patient Health Questionnaire-9 score more than 15), central nervous system disease (including but not limited to any type of seizure or stroke), and no cognitive behavior (including the investigator considers poor adherence to evaluate efficacy or is unlikely to complete the intended course and follow-up).

Trial locations and contacts

No sites are listed yet.

Ping Li, MD contact

15296791363

lp06010319@163.com

About this study

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

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.

Read the 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 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.

Being tested
Canagliflozin 100mg Tab, Metformin Hydrochloride
Medical subject headings
Polycystic Ovary Syndrome, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Canagliflozin 100mg TabDrug

    Also called Invokana

    Canagliflozin 100mg once daily combined Metformin 1000mg twice daily

  • Metformin HydrochlorideDrug

    Also called Glucophage

    Metformin 1000mg twice daily

Study groups in NCT06256289
Study groupRoleWhat they receive
canagliflozin plus metformin groupExperimentalcanagliflozin 100 mg once daily plus metformin 1000 mg twice daily
Receives: Drug: Canagliflozin 100mg Tab; Drug: Metformin Hydrochloride
metformin groupActive comparatormetformin 1000 mg twice daily
Receives: Drug: Metformin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. liver steatosis index CAP (Controlled Attenuation Parameter) measured by FibroScan

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

    Measured: at baseline and 12 weeks

Secondary outcomes (6)

  1. liver stiffness index (LS） measured by transient elastography, FibroScan

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

    Measured: at baseline and 12 weeks

  2. Body Composition, including total body water, muscle mass, fat mass (subcutaneous and visceral), fat-free mass detected using Bioelectrical Impedance Analysis (BIA)

    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.

    Measured: at baseline and 12 weeks

  3. selection of proteomics markers using liquid chromatography-tandem mass spectrometry (LC-MS/MS) mass spectrometry for analysis

    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.

    Measured: at baseline and 12 weeks

  4. selection of metabolomics markers by by liquid chromatography-tandem mass spectrometry (LC-MS/MS) mass spectrometryprecision

    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)

    Measured: at baseline and 12 weeks

  5. sex hormones by liquid chromatography-tandem mass spectrometry (LC-MS/MS) mass spectrometry

    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

    Measured: at baseline and after 12 weeks

  6. Gut Microbiota diversity sequencing by 16s rRNA Amplicon Sequencing Analysis

    Gut microbiome testing equipment includes sterile samplers for sample collection, DNA extraction kits, PCR machines for amplification, high-throughput sequencing platforms for analysis, bioinformatics software for data processing, and AI systems for advanced analysis. These tools enable precise and efficient assessment of gut microbial composition, aiding in understanding its impact on disease and informing clinical treatments.

    Measured: at baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start31 Mar 2024 (estimated)
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06256289
Sponsor's protocol ID
FirstofShanxiMU
Status last verified
Feb 2024
First submitted
28 Jan 2024
Last updated
13 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rocha ALL, Faria LC, Guimaraes TCM, Moreira GV, Candido AL, Couto CA, Reis FM. Non-alcoholic fatty liver disease in women with polycystic ovary syndrome: systematic review and meta-analysis. J Endocrinol Invest. 2017 Dec;40(12):1279-1288. doi: 10.1007/s40618-017-0708-9. Epub 2017 Jun 13.

    PubMed 28612285

  • Makri E, Tziomalos K. Prevalence, etiology and management of non-alcoholic fatty liver disease in patients with polycystic ovary syndrome. Minerva Endocrinol. 2017 Jun;42(2):122-131. doi: 10.23736/S0391-1977.16.02564-5. Epub 2016 Oct 28.

    PubMed 27792214

  • De Sousa SM Dr, Norman RJ Prof. Metabolic syndrome, diet and exercise. Best Pract Res Clin Obstet Gynaecol. 2016 Nov;37:140-151. doi: 10.1016/j.bpobgyn.2016.01.006. Epub 2016 Feb 10.

    PubMed 26972165

  • Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.

    PubMed 14711538

  • Macut D, Tziomalos K, Bozic-Antic I, Bjekic-Macut J, Katsikis I, Papadakis E, Andric Z, Panidis D. Non-alcoholic fatty liver disease is associated with insulin resistance and lipid accumulation product in women with polycystic ovary syndrome. Hum Reprod. 2016 Jun;31(6):1347-53. doi: 10.1093/humrep/dew076. Epub 2016 Apr 12.

    PubMed 27076501

  • March WA, Moore VM, Willson KJ, Phillips DI, Norman RJ, Davies MJ. The prevalence of polycystic ovary syndrome in a community sample assessed under contrasting diagnostic criteria. Hum Reprod. 2010 Feb;25(2):544-51. doi: 10.1093/humrep/dep399. Epub 2009 Nov 12.

    PubMed 19910321

  • Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Androgen Excess Society. Positions statement: criteria for defining polycystic ovary syndrome as a predominantly hyperandrogenic syndrome: an Androgen Excess Society guideline. J Clin Endocrinol Metab. 2006 Nov;91(11):4237-45. doi: 10.1210/jc.2006-0178. Epub 2006 Aug 29.

    PubMed 16940456

  • Teede HJ, Hutchison SK, Zoungas S. The management of insulin resistance in polycystic ovary syndrome. Trends Endocrinol Metab. 2007 Sep;18(7):273-9. doi: 10.1016/j.tem.2007.08.001. Epub 2007 Aug 16.

    PubMed 17698366

  • Meyer C, McGrath BP, Teede HJ. Overweight women with polycystic ovary syndrome have evidence of subclinical cardiovascular disease. J Clin Endocrinol Metab. 2005 Oct;90(10):5711-6. doi: 10.1210/jc.2005-0011. Epub 2005 Jul 26.

    PubMed 16046590

  • Wild RA, Painter PC, Coulson PB, Carruth KB, Ranney GB. Lipoprotein lipid concentrations and cardiovascular risk in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 1985 Nov;61(5):946-51. doi: 10.1210/jcem-61-5-946.

    PubMed 4044782

  • Mantovani A, Byrne CD, Scorletti E, Mantzoros CS, Targher G. Efficacy and safety of anti-hyperglycaemic drugs in patients with non-alcoholic fatty liver disease with or without diabetes: An updated systematic review of randomized controlled trials. Diabetes Metab. 2020 Nov;46(6):427-441. doi: 10.1016/j.diabet.2019.12.007. Epub 2020 Jan 7.

    PubMed 31923578

  • Itani T, Ishihara T. Efficacy of canagliflozin against nonalcoholic fatty liver disease: a prospective cohort study. Obes Sci Pract. 2018 Aug 22;4(5):477-482. doi: 10.1002/osp4.294. eCollection 2018 Oct.

    PubMed 30338118

  • Cai M, Shao X, Xing F, Zhang Y, Gao X, Zeng Q, Dilimulati D, Qu S, Zhang M. Efficacy of canagliflozin versus metformin in women with polycystic ovary syndrome: A randomized, open-label, noninferiority trial. Diabetes Obes Metab. 2022 Feb;24(2):312-320. doi: 10.1111/dom.14583. Epub 2021 Nov 25.

    PubMed 34726324

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Canagliflozin 100mg Tab and Metformin Hydrochloride in people with Polycystic Ovary Syndrome and Non-Alcoholic Fatty Liver Disease, run by Ping Li,MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ping Li, MD (15296791363, lp06010319@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

liver steatosis index CAP (Controlled Attenuation Parameter) measured by FibroScan (time frame: at baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06256289, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.

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