PCOS Immune Function Predicts Metformin Efficacy
- Conditions
- MetforminImmune FunctionPolycystic Ovary Syndrome
- Interventions
- Registration Number
- NCT06325956
- Lead Sponsor
- Shanghai 10th People's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- aged 18-45 years
- Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metformin therapy Metformin Metformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment.
- Primary Outcome Measures
Name Time Method The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. Samples to be collected once per participant within 7 days of enrollment. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. Samples to be collected once per participant within 7 days of enrollment. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
- Secondary Outcome Measures
Name Time Method Triglycerides Within 7 days of enrollment. Triglycerides (mmol/L)
body mass index Within 7 days of enrollment. body mass index (kg/m2)
fasting glucose Within 7 days of enrollment. fasting glucose (mmol/L)
Total cholesterol Within 7 days of enrollment. Total cholesterol (mmol/L)
Homeostasis model assessment of insulin resistance Within 7 days of enrollment. insulin resistance index
fasting insulin Within 7 days of enrollment. fasting insulin (mmol/L)
total testosterone Within 7 days of enrollment. total testosterone (nmol/L)
menstrual frequency Within 7 days of enrollment. number of menstruation in a year
Androstenedione Within 7 days of enrollment. Androstenedione (ng/ml)
HDL-c Within 7 days of enrollment. HDL-c (mmol/L)
LDL-c Within 7 days of enrollment. LDL-c (mmol/L)
Dehydroepiandrosterone Within 7 days of enrollment. Dehydroepiandrosterone (ug/dl)
free testosterone Within 7 days of enrollment. free testosterone (nmol/L)
Sex hormone-binding globulin Within 7 days of enrollment. Sex hormone-binding globulin (nmol/L)
Trial Locations
- Locations (1)
Department of Endocrinology, Shanghai Tenth People's Hospital
🇨🇳Shanghai, China