Clinical trial NCT06325956: PCOS Immune Function Predicts Metformin Efficacy
Official title: Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Metformin
Immune Function
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.

Detailed description: In this study, peripheral blood samples of PCOS patients were collected before and after intervention. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescently labeled antibodies in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.

Eligibility criteria: Inclusion Criteria:

* aged 18-45 years
* Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)

Exclusion Criteria:

* Pregnant women;
* Hyperthyroidism or hypothyroidism
* Severe liver and kidney function injury
* Cancer patients;
* Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
* Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
* Patients with mental illness or intellectual disability;
* Have taken drugs for PCOS treatment in the last three months;
* Have a long history of taking hormone therapy;
* Currently or recently participating in another clinical trial.

Primary outcomes:
measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
Secondary outcomes:
measure: Homeostasis model assessment of insulin resistance
timeFrame: Within 7 days of enrollment.
measure: body mass index
timeFrame: Within 7 days of enrollment.
measure: menstrual frequency
timeFrame: Within 7 days of enrollment.
measure: fasting glucose
timeFrame: Within 7 days of enrollment.
measure: fasting insulin
timeFrame: Within 7 days of enrollment.
measure: Total cholesterol
timeFrame: Within 7 days of enrollment.
measure: Triglycerides
timeFrame: Within 7 days of enrollment.
measure: HDL-c
timeFrame: Within 7 days of enrollment.
measure: LDL-c
timeFrame: Within 7 days of enrollment.
measure: total testosterone
timeFrame: Within 7 days of enrollment.
measure: free testosterone
timeFrame: Within 7 days of enrollment.
measure: Sex hormone-binding globulin
timeFrame: Within 7 days of enrollment.
measure: Androstenedione
timeFrame: Within 7 days of enrollment.
measure: Dehydroepiandrosterone
timeFrame: Within 7 days of enrollment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Manna Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References: