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

NCT05463627 | Unknown

• 1 other identifier: KY2021-184-B
• Study Type: observational
• Target: 1,440
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Metformin

Outcome Measures

Primary Outcomes (1)

• Reversed insulin resistance or restored glucose homeostasis in women with PCOS

  Compared with the baseline in three groups, the rate of reversed insulin resistance or restored glucose homeostasis

  5 years

Secondary Outcomes (20)

• change in the level of BMI

  5 years

• change in the level of glycated hemoglobin(HbA1c)

  5 years

• change in the level of 0'-180'Plasma Glucose(PG)

  5 years

• change in the level of 0'-180'insulin(ins)

  5 years

• change in the level of 0'-180'C-Peptide

  5 years

Study Arms (3)

BMI<24 kg/m2

women diagnosed with PCOS with BMI\<24 kg/m2

Drug: Metformin

BMI24-28 kg/m2

women diagnosed with PCOS with BMI24-28 kg/m2

Drug: Metformin

BMI>28 kg/m2

women diagnosed with PCOS with BMI\>28kg/m2

Drug: Metformin

Interventions

Metformin DRUG

All participants among the three groups were treated with metformin

Also known as: melbine

BMI24-28 kg/m2; BMI<24 kg/m2; BMI>28 kg/m2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Obese,overweight and normal-weight women aged 18-45 years (in childbearing age)with PCOS or/and IGR/DM were expected enrolled in our study

You may qualify if:

• Females at the age of 18-45years old;
• Diagnosed with PCOS or/and impaired glucose regulation (IGR)/diabetes(DM)
• Metformin regimens were used without other metabolic agents
• 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.

You may not qualify if:

• 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;
• Participated in clinical trials of other drugs within 3 months;
• 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;
• A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
• Any conditions judged by the investigator that affect enrollment.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (3)

• Pedersen AJT, Stage TB, Glintborg D, Andersen M, Christensen MMH. The Pharmacogenetics of Metformin in Women with Polycystic Ovary Syndrome: A Randomized Trial. Basic Clin Pharmacol Toxicol. 2018 Feb;122(2):239-244. doi: 10.1111/bcpt.12874. Epub 2017 Sep 19.

  PMID: 28834135 BACKGROUND

• Li Y, Tan J, Wang Q, Duan C, Hu Y, Huang W. Comparing the individual effects of metformin and rosiglitazone and their combination in obese women with polycystic ovary syndrome: a randomized controlled trial. Fertil Steril. 2020 Jan;113(1):197-204. doi: 10.1016/j.fertnstert.2019.09.011. Epub 2019 Nov 9.

  PMID: 31718828 BACKGROUND

• Xiong F, Xiao J, Bai Y, Zhang Y, Li Q, Lishuang X. Metformin inhibits estradiol and progesterone-induced decidualization of endometrial stromal cells by regulating expression of progesterone receptor, cytokines and matrix metalloproteinases. Biomed Pharmacother. 2019 Jan;109:1578-1585. doi: 10.1016/j.biopha.2018.10.128. Epub 2018 Nov 15.

  PMID: 30551411 BACKGROUND

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

• Tao Tao, Dr.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Tao, Dr.

CONTACT

86-021-68383073; taotaosh76@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: July 19, 2022
• Study Start: January 1, 2016
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)