PCOS Immune Function Predicts Metformin Efficacy

Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome; Immune Function; Metformin
• Intervention / Treatment: Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manna Zhang, doctor; Phone Number: +8613774448495; Email: mannazhang@126.com

Study Locations

• China
  • Shanghai, China, 200072
    • Recruiting
    • Department of Endocrinology, Shanghai Tenth People's Hospital
    • Contact: Manna Zhang, Doctor; Phone Number: 86-21-66301004; Email: mannazhang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin therapy; Metformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment.	Drug: Metformin; Take metformin for six months.; Other Names: Metformin therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Samples to be collected once per participant within 7 days of enrollment.
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.	Samples to be collected once per participant within 7 days of enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homeostasis model assessment of insulin resistance	insulin resistance index	Within 7 days of enrollment.
body mass index	body mass index (kg/m2)	Within 7 days of enrollment.
menstrual frequency	number of menstruation in a year	Within 7 days of enrollment.
fasting glucose	fasting glucose (mmol/L)	Within 7 days of enrollment.
fasting insulin	fasting insulin (mmol/L)	Within 7 days of enrollment.
Total cholesterol	Total cholesterol (mmol/L)	Within 7 days of enrollment.
Triglycerides	Triglycerides (mmol/L)	Within 7 days of enrollment.
HDL-c	HDL-c (mmol/L)	Within 7 days of enrollment.
LDL-c	LDL-c (mmol/L)	Within 7 days of enrollment.
total testosterone	total testosterone (nmol/L)	Within 7 days of enrollment.
free testosterone	free testosterone (nmol/L)	Within 7 days of enrollment.
Sex hormone-binding globulin	Sex hormone-binding globulin (nmol/L)	Within 7 days of enrollment.
Androstenedione	Androstenedione (ng/ml)	Within 7 days of enrollment.
Dehydroepiandrosterone	Dehydroepiandrosterone (ug/dl)	Within 7 days of enrollment.

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Manna Zhang, doctor, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: Immune status and metformin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No