SGLT2 Inhibitors in Treating Patients With PCOS

NCT ID: NCT05966792

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2025-06-30

Brief Summary

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;

Detailed Description

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 108 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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SGLT2 inhibitors

Intervention with henggliflozin (10mg qd) for 6 months

Group Type: EXPERIMENTAL

SGLT2 inhibitors

Intervention Type: 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

Intervention with metformin (500mg bid) for 6 months

Group Type: PLACEBO_COMPARATOR

metformin

Intervention Type: DRUG

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

Interventions

SGLT2 inhibitors

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.

Intervention Type: DRUG

metformin

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Manna

Director, principal investigator, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manna Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

Shanghai Tenth People'S Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SGLT2i in PCOS

Identifier Type: -

Identifier Source: org_study_id