Actively Recruiting
Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome
Led by Shanghai 10th People's Hospital · Updated on 2024-03-22
100
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women with Polycystic Ovary Syndrome (PCOS) to understand how immune function relates to the effects of metformin treatment. This study aims to identify immune markers that may help predict how well metformin works for individuals with PCOS. The study is interventional and led by Shanghai 10th People's Hospital. Participants will receive metformin, starting with 1000 mg daily for the first week and increasing to 1500 mg daily from the second week through six months. Blood samples will be collected before and after treatment to analyze immune cell markers using flow cytometry. The study focuses on changes in immune cell groups and their relationship to metformin's effects. During the study, participants will have blood tests within 7 days of enrollment to measure various immune markers and metabolic indicators such as insulin resistance, glucose levels, body mass index, hormone levels, and lipid profiles. Researchers will track menstrual frequency and other health factors. The total participation involves treatment and follow-up over six months, with safety and outcomes carefully monitored throughout.
CONDITIONS
Brief Title
PCOS Immune Function Predicts Metformin Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-45 years
- Diagnosis of PCOS using the Rotterdam diagnosis criteria (2003)
You will not qualify if you...
- Pregnant women
- Hyperthyroidism or hypothyroidism
- Severe liver and kidney function injury
- Cancer patients
- Severe infection, severe anemia, neutropenia, or other blood system diseases
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take metformin daily for six months to treat PCOS.
1 baseline visit within 7 days of enrollment
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, China, 200072
Actively Recruiting
Research Team
M
Manna Zhang, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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