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Trial Title:
SGLT2 Inhibitors in Treating Patients with PCOS
NCT ID:
NCT05966792
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Metformin
Sodium-Glucose Transporter 2 Inhibitors
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SGLT2 inhibitors
Description:
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.
Arm group label:
SGLT2 inhibitors
Intervention type:
Drug
Intervention name:
metformin
Description:
Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can
improve the degree of insulin resistance in PCOS patients.
Arm group label:
metformin
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Tenth People'S Hospital
Address:
City:
Shanghai
Zip:
200072
Country:
China
Start date:
November 10, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Shanghai 10th People's Hospital
Agency class:
Other
Source:
Shanghai 10th People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05966792
