PCOS Immune Function Predicts Metformin Efficacy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorShanghai 10th People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 18-45 years
Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
Disqualifiers
Pregnant women;
Hyperthyroidism or hypothyroidism
Severe liver and kidney function injury
Cancer patients;
Trial design
Design model
Single group
Treatments tested in this trial
Metformin
DrugTake metformin for six months.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Metformin therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
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.
Time frame
Samples to be collected once per participant within 7 days of enrollment.2
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
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.
Time frame
Samples to be collected once per participant within 7 days of enrollment.Secondary outcomes
1
Homeostasis model assessment of insulin resistance
insulin resistance index
Time frame
Within 7 days of enrollment.2
body mass index
body mass index (kg/m2)
Time frame
Within 7 days of enrollment.3
menstrual frequency
number of menstruation in a year
Time frame
Within 7 days of enrollment.4
fasting glucose
fasting glucose (mmol/L)
Time frame
Within 7 days of enrollment.Sponsors and contacts
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Source ClinicalTrials.gov