Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Metformin

Sodium-Glucose Transporter 2 Inhibitors

Intervention with henggliflozin (5mg qd) and metformin (500mg bid) for 3 months

Intervention with placebo (qd) and metformin (500mg bid) for 3 months

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.

SGLT2 inhibitors combined with metformin

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

Placebo combined with metformin

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

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 72 patients enrolled.

Subjects randomized to the trial group will receive SGLT-2 inhibitors plus metformin for 12 weeks.

Participants randomised to control will receive placebo plus metformin for 12 weeks.

SGLT2 Inhibitors in Treating Patients With PCOS

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

Homeostatic model assessment insulin resistance index

Shanghai 10th People's Hospital

Director, principal investigator, clinical professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SGLT2 Inhibitors in Treating Patients With PCOS	NCT05966792	Polycystic Ovar...	SGLT2 inhibitor... Placebo combine...	18 Years - 45 Years	Shanghai 10th People's Hospital
SGLT2 Inhibitors in Treating Patients With PCOS	NCT05966792	Polycystic Ovar...	SGLT2 inhibitor... Placebo combine...	18 Years - 45 Years	Shanghai 10th People's Hospital

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