Effects of Metformin on Metabolic and Reproductive Outcomes in Chinese PCOS Patients

• Conditions: Polycystic Ovary Syndrome; Metformin
• Interventions: Drug: Metformin

• Registration Number: NCT05463627
• Lead Sponsor: RenJi Hospital

Brief Summary

Polycystic ovary syndrome (PCOS) is a reproductive endocrine disease characterized by reproductive and metabolic abnormalities, which is a crucial cause of female infertility and an essential risk factor for type 2 diabetes. At present, there exist several clinical trials and studies on the usage of metformin in the treatment of PCOS patients in prediabetes, and the practical application of metformin in clinical practice has years of history. The treatment plan of metformin is of great significance in preventing type 2 diabetes in PCOS patients and assisting pregnancy in PCOS infertile patients.

Detailed Description

The purpose of this study is to conduct a real world study on effects of metformin on the improvement of metabolism and reproductive outcome in Chinese prediabetic PCOS patients by collecting relevant medical system records from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine as real world data and a significant supplement to clinical trial studies. At the same time, obese and non-obese PCOS patients may have different mechanisms of insulin resistance, so this study stratified PCOS patients to analyze whether metformin can improve treatment results for PCOS patients with prediabetes according to different body mass index (BMI).The investigator's study is the first real world study to investigate Chinese pre-diabetes PCOS patients treated by metformin and the metabolic and reproductive outcomes, which is innovative. The investigator's research also has a guiding significance for the practical application of metformin in improving glucose metabolism and reproductive outcomes in patients with different body weight in clinical practice, and has great relevance for PCOS patients to reduce long-term complications and improve quality of life.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-07-17
• Last Update Submitted: 2022-07-17
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1440

Inclusion Criteria

1. Females at the age of 18-45years old;
2. Diagnosed with PCOS or/and impaired glucose regulation (IGR)/diabetes(DM)
3. Metformin regimens were used without other metabolic agents
4. The diagnosis of PCOS is based on the 2003 Rotterdam criteria and the diagnostic criteria for impaired glucose regulation (IGR) and type 2 diabetes are based on the 2021 American Diabetes Association(ADA) diagnosis criteria.

Exclusion Criteria

1. Severe liver and kidney dysfunction (ALT is greater than 2.5 times the upper limit of normal, or Cr>132umol/l, or eGFR <60 mL/min/1.73m2), psychosis, accompanied by severe infection, severe anemia, neutropenia disease;
2. Participated in clinical trials of other drugs within 3 months;
3. In the past 5 years, there have been treated or untreated organ system tumors (except local skin basal cell carcinoma), regardless of whether there is evidence of local recurrence or metastasis;
4. A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
5. Any conditions judged by the investigator that affect enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BMI<24 kg/m2	Metformin	women diagnosed with PCOS with BMI\<24 kg/m2
BMI>28 kg/m2	Metformin	women diagnosed with PCOS with BMI\>28kg/m2
BMI24-28 kg/m2	Metformin	women diagnosed with PCOS with BMI24-28 kg/m2

Primary Outcome Measures

Name	Time	Method
Reversed insulin resistance or restored glucose homeostasis in women with PCOS	5 years	Compared with the baseline in three groups, the rate of reversed insulin resistance or restored glucose homeostasis

Secondary Outcome Measures

Name	Time	Method
change in the level of Follicle stimulating hormone(FSH)	5 years	Compared with the baseline in three groups, the level of FSH is one of the metabolic index to evaluate Reproductive outcome
change in the level of BMI	5 years	Compared with the baseline in three groups, the level of BMI is one of the metabolic index to evaluate metabolic outcome
change in the level of glycated hemoglobin(HbA1c)	5 years	Compared with the baseline in three groups, the level of HbA1c is one of the metabolic index to evaluate glucose metabolic outcome
change in the level of 0'-180'Plasma Glucose(PG)	5 years	Compared with the baseline in three groups, the level of 0'-180'PG from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome
change in the level of 0'-180'insulin(ins)	5 years	Compared with the baseline in three groups, the level of 0'-180'ins from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome
change in the level of 0'-180'C-Peptide	5 years	Compared with the baseline in three groups, the level of 0'-180'C-Peptide from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome
change in the level of β cell homeostatic model assessment(HOMA-β)	5 years	Compared with the baseline in three groups, the level of HOMA-β calculated from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome
change in the level of Matsuda Index(MI)	5 years	Compared with the baseline in three groups, the level of MI calculated from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome
change in the level of deposition index(DI)	5 years	Compared with the baseline in three groups, the level of DI calculated from oral glucose tolerance test is one of the metabolic index to evaluate glucose metabolic outcome
change in the level of Prolactin(PRL)	5 years	Compared with the baseline in three groups, the level of PRL is one of the metabolic index to evaluate Reproductive outcome
change in the level of waist-hip ratio(WHR)	5 years	Compared with the baseline in three groups, the level of WHR is one of the metabolic index to evaluate metabolic outcome
change in the level of estradiol(E2)	5 years	Compared with the baseline in three groups, the level of E2 is one of the metabolic index to evaluate Reproductive outcome
change in the level of Luteinizing hormone(LH)	5 years	Compared with the baseline in three groups, the level of LH is one of the metabolic index to evaluate Reproductive outcome
live birth rate	5 years	Compared with the baseline in three groups, live birth rate is one of the index to evaluate Reproductive outcome
change in the level of testosterone(T)	5 years	Compared with the baseline in three groups, the level of T is one of the metabolic index to evaluate Reproductive outcome
change in the level of Sex hormone-binding globulin(SHBG)	5 years	Compared with the baseline in three groups, the level of SHBG is one of the metabolic index to evaluate Reproductive outcome
change in the level of Dehydroepiandrosterone sulfate(DHEAS)	5 years	Compared with the baseline in three groups, the level of DHEAS is one of the metabolic index to evaluate Reproductive outcome
change in the level of Androstenedione(A2)	5 years	Compared with the baseline in three groups, the level of A2 is one of the metabolic index to evaluate Reproductive outcome
pregnancy rate	5 years	Compared with the baseline in three groups, pregnancy rate is one of the index to evaluate Reproductive outcome
improvement rate of menstrual cycle	5 years	Compared with the baseline in three groups, improvement rate of menstrual cycle is one of the index to evaluate Reproductive outcome

Trial Locations

Locations (1)

Renji Hospital Department of Endocrinology and Metabolism; 🇨🇳 Shanghai, Shanghai, China