Immune Function, Metformin, Polycystic Ovary Syndrome
Conditions
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.
Interventions
DRUGMetformin
Take metformin for six months.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total testosterone | Within 7 days of enrollment. | total testosterone (nmol/L) |
| 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) |
| Androstenedione | Within 7 days of enrollment. | Androstenedione (ng/ml) |
| Dehydroepiandrosterone | Within 7 days of enrollment. | Dehydroepiandrosterone (ug/dl) |
| Homeostasis model assessment of insulin resistance | Within 7 days of enrollment. | insulin resistance index |
| HDL-c | Within 7 days of enrollment. | HDL-c (mmol/L) |
| menstrual frequency | Within 7 days of enrollment. | number of menstruation in a year |
| fasting glucose | Within 7 days of enrollment. | fasting glucose (mmol/L) |
| fasting insulin | Within 7 days of enrollment. | fasting insulin (mmol/L) |
| Total cholesterol | Within 7 days of enrollment. | Total cholesterol (mmol/L) |
| Triglycerides | Within 7 days of enrollment. | Triglycerides (mmol/L) |
| body mass index | Within 7 days of enrollment. | body mass index (kg/m2) |
| LDL-c | Within 7 days of enrollment. | LDL-c (mmol/L) |
Countries
China
Contacts
Primary ContactManna Zhang, doctor
Outcome results
None listed