NCT05146063

Brief Summary

Insulin resistance (IR) is an important pathological feature of polycystic ovary syndrome (PCOS), with an incidence rate of up to 85%, which seriously affects the patient's fertility, quality of life, and offspring health, but the mechanism is unknown. The adaptor protein LNK is closely related to metabolic diseases. Our exome sequencing has found that the mutation rate of LNK gene in patients with PCOS and IR is high. Studies have found that LNK can affect adipose inflammation and impair glucose tolerance. Whether LNK is related to fat metabolism is worth further study. Our previous research found that: LNK expression was significantly increased in adipose tissue of patients with PCOS and IR. Knockout of LNK in PCOS IR model mice can reduce serum triglycerides, free fatty acids, high-sensitivity C-reactive protein levels and reduce fatty liver occurrence, which indicates that LNK has a mitigating effect on IR. Mechanism studies have shown that LNK knockout can upregulate the glucose transporter Glut4, also LNK and insulin receptor substrate IRS-1 can form protein complexes. Based on the above research basis, we propose the following scientific hypothesis: LNK in adipose tissue can regulate insulin signaling pathway by binding to IRS-1, downregulate Glut4, and participate in PCOS IR occurrence. This project intends to clarify the specific mechanism by which LNK regulates glucose transport and participate in IR in combination with clinical specimens, animal models and cell experiments, and provide scientific basis for LNK as a potential therapeutic target for PCOS IR.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

November 11, 2021

Last Update Submit

November 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • mRNA expression levels of LNK

    The expression level of LNK mRNA in the subcutaneous adipose tissue of the PCOS patients

    2 years

  • protein expression levels of LNK

    The expression level of LNK protein in the subcutaneous adipose tissue of the PCOS patients

    2 years

Study Arms (2)

Polycystic ovary syndrome patients with insulin resistance

Diagnostic Test: Take the patient's subcutaneous fat tissue to detect the expression of LNK

Polycystic ovary syndrome patients without insulin resistance

Diagnostic Test: Take the patient's subcutaneous fat tissue to detect the expression of LNK

Interventions

Take the patient's subcutaneous fat tissue to detect the mRNA and protein expression levels of LNK by RT-qPCR and western blot.

Polycystic ovary syndrome patients with insulin resistancePolycystic ovary syndrome patients without insulin resistance

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with polycystic ovary syndrome who met the 2003 Rotterdam criteria were divided into insulin resistance group and non-insulin resistance group

You may qualify if:

  • Patients with polycystic ovary syndrome who meet the 2003 Rotterdam criteria

You may not qualify if:

  • Do not meet the diagnostic criteria for polycystic ovary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yi Zhang

    Sun Yat-sen Memorial Hospital, Sun Yat-sen Univers

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 6, 2021

Study Start

November 5, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

December 6, 2021

Record last verified: 2021-11

Locations