NCT05966792Completed
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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;
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 21 Jul 2023
- Start date
- 10 Nov 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Shanghai 10th People's Hospital
- NCT number
- NCT05966792
What you commit to
- Study type: Interventional
- Participants enrolled: 82
- From 10 Nov 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Mental illness
- Malignant tumors
- Chronic kidney disease or severe liver dysfunction
- Inflammatory bowel disease
Other
- Pregnancy or lactation
- Involvement in other research programs within the past 3 months
Who the study is looking for
- Female aged 18-45
- Meet Rotterdam criteria
- BMI≥20kg/m2
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.