SGLT2 Inhibitors in Treating Patients With PCOS

NCT05966792 | Completed

• 1 other identifier: SGLT2i in PCOS
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Menstrual cycles

  annual number of menstrual cycles

  6 months

Secondary Outcomes (11)

• HOMA-IR

  6 months

• NLRP3

  6 months

• IL-1β

  6 months

• IL-18

  6 months

• LH

  6 months

Study Arms (2)

SGLT2 inhibitors

EXPERIMENTAL

Intervention with henggliflozin (10mg qd) for 6 months

Drug: SGLT2 inhibitors

metformin

PLACEBO COMPARATOR

Intervention with metformin (500mg bid) for 6 months

Drug: metformin

Interventions

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.

SGLT2 inhibitors

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.

metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People'S Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Sodium-Glucose Transporter 2 Inhibitors; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Manna Zhang, PhD

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, principal investigator, clinical professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: November 10, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)