PCOS Immune Function Predicts Metformin Efficacy

NCT06325956 | Recruiting DMC

• 1 other identifier: Immune status and metformin
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Metformin; Immune Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Homeostasis model assessment of insulin resistance

  Within 7 days of enrollment.

• body mass index

  Within 7 days of enrollment.

• menstrual frequency

  Within 7 days of enrollment.

• fasting glucose

  Within 7 days of enrollment.

• fasting insulin

  Within 7 days of enrollment.

Study Arms (1)

Metformin therapy

EXPERIMENTAL

Metformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment.

Drug: Metformin

Interventions

Metformin DRUG

Take metformin for six months.

Also known as: Metformin therapy

Metformin therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-45 years
• Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Manna Zhang, doctor

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manna Zhang, doctor

CONTACT

+8613774448495; mannazhang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 22, 2024
• Study Start: March 16, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)