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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05146063
Other study ID # SYSEC-KY-KS-2021-187
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 5, 2021
Est. completion date December 31, 2023

Study information

Verified date November 2021
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Yi Zhang
Phone +862081332120
Email sys_iit@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Patients with polycystic ovary syndrome who meet the 2003 Rotterdam criteria Exclusion Criteria: - Do not meet the diagnostic criteria for polycystic ovary syndrome

Study Design


Intervention

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

Locations

Country Name City State
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary mRNA expression levels of LNK The expression level of LNK mRNA in the subcutaneous adipose tissue of the PCOS patients 2 years
Primary protein expression levels of LNK The expression level of LNK protein in the subcutaneous adipose tissue of the PCOS patients 2 years
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