Polycystic Ovary Syndrome
Conditions
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.
Interventions
DRUGSGLT2 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.
DRUGmetformin
Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual cycles | 6 months | annual number of menstrual cycles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NLRP3 | 6 months | serum Nod-like receptor protein 3 |
| IL-1β | 6 months | serum Interleukin-1 beta |
| IL-18 | 6 months | serum Interleukin-18 |
| LH | 6 months | luteinizing hormone |
| FSH | 6 months | follicle-stimulating hormone |
| HOMA-IR | 6 months | Homeostatic model assessment insulin resistance index |
| E2 | 6 months | estradiol |
| P | 6 months | progesterone |
| TT | 6 months | total testosterone |
| AMH | 6 months | antimullerian hormone antimullerian hormone antimullerian hormone antimullerian hormone |
| PRL | 6 months | prolactin |
Countries
China
Outcome results
None listed