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NCT Number: NCT05966792

SGLT2 Inhibitors in Treating Patients With PCOS

Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Metformin is a classic endocrine drug for the treatment of PCOS, but its clinical response rate is only about 40%. Our previous published study (Diabetes Obes Metab, 2022) observed that the new hypoglycemic drug SGLT-2 inhibitor can significantly improve the clinical symptoms of patients with insulin resistance PCOS, and the clinical efficacy is not inferior to metformin, but its specific mechanism of action is not clear. Recent studies have shown that SGLT-2 significantly attenuates the activation of the Nod-like receptor protein 3 (NLRP3) inflammasomes and the secretion of IL-1β in patients with type 2 diabetes mellitus at high risk of cardiovascular disease. Based on the above research background, this project will combine clinical research and mechanism exploration to solve the following two problems:

1. whether SGLT2 inhibitor can further improve the clinical efficacy of PCOS patients compared to metformin; 2. mechanistic studies further clarify whether SGLT2 inhibitors improve inflammatory symptoms by modulating NLRP3 inflammosomes in the treatment of polycystic ovary syndrome;

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People'S Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

This clinical study is a prospective, single-center, randomized (1:1) controlled clinical study. The enrollment population is overweight or obese PCOS patients. After signing the informed consent form, patients who meet the inclusion/exclusion criteria will be randomly assigned to the experimental and control groups for treatment in a 1:1 ratio, for a total of 80 patients enrolled.

Subjects randomized to the trial group will receive SGLT-2 inhibitors for 24 weeks.

Participants randomised to control will receive metformin for 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female aged 18-45
  • Meet Rotterdam criteria
  • BMI≥20kg/m2

Exclusion criteria

  • Treatment with any additional medications that might impede the trial, including GLP-1 RAs, metformin, pioglitazone, contraceptives, or traditional Chinese medicine within the past 3 months
  • Pregnancy or lactation
  • Mental illness
  • Malignant tumors
  • Chronic kidney disease or severe liver dysfunction
  • Inflammatory bowel disease
  • Involvement in other research programs within the past 3 months

Treatment and study plan

SGLT2 inhibitors

Drug

Sodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet β-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet β-cell function, and reducing oxidative stress.

metformin

Drug

Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.

Primary outcomes

  1. Menstrual cycles

    Time frame: 6 months

    annual number of menstrual cycles

Secondary outcomes

  1. HOMA-IR

    Time frame: 6 months

    Homeostatic model assessment insulin resistance index

  2. NLRP3

    Time frame: 6 months

    serum Nod-like receptor protein 3

  3. IL-1β

    Time frame: 6 months

    serum Interleukin-1 beta

  4. IL-18

    Time frame: 6 months

    serum Interleukin-18

  5. LH

    Time frame: 6 months

    luteinizing hormone

  6. FSH

    Time frame: 6 months

    follicle-stimulating hormone

  7. PRL

    Time frame: 6 months

    prolactin

  8. E2

    Time frame: 6 months

    estradiol

  9. P

    Time frame: 6 months

    progesterone

  10. TT

    Time frame: 6 months

    total testosterone

  11. AMH

    Time frame: 6 months

    antimullerian hormone antimullerian hormone antimullerian hormone antimullerian hormone

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

The Clinical Efficacy and Mechanism of SGLT2 Inhibitors Treating Polycystic Ovary Syndrome by Modulating the Nod-like Receptor Protein 3 Inflammasome

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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