Polycystic Ovarian SyndromeNCT05146063
LNK in Polycystic Ovary Syndrome With Insulin Resistance
An observational study of Polycystic Ovarian Syndrome and Insulin Resistance, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Insulin Resistance
- What is being tested?
- Take the patient's subcutaneous fat tissue to detect the expression of LNK
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with polycystic ovary syndrome who met the 2003 Rotterdam criteria were divided into insulin resistance group and non-insulin resistance group
Who may be able to join
- Patients with polycystic ovary syndrome who meet the 2003 Rotterdam criteria
Who cannot join
- Do not meet the diagnostic criteria for polycystic ovary syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Xiaozhu Zhong, Doctor, 02081332233
About this study
Official title: LNK Participates in Insulin Resistance in Polycystic Ovary Syndrome by Regulating Adipose Glucose Transport
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.
- Conditions
- Polycystic Ovarian Syndrome, Insulin Resistance
- Being tested
- Take the patient's subcutaneous fat tissue to detect the expression of LNK
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take the patient's subcutaneous fat tissue to detect the expression of LNKDiagnostic test
Take the patient's subcutaneous fat tissue to detect the mRNA and protein expression levels of LNK by RT-qPCR and western blot.
| Study group | Role | What they receive |
|---|---|---|
| Polycystic ovary syndrome patients with insulin resistance | Not described Receives: Diagnostic Test: Take the patient's subcutaneous fat tissue to detect the expression of LNK | |
| Polycystic ovary syndrome patients without insulin resistance | Not described Receives: Diagnostic Test: Take the patient's subcutaneous fat tissue to detect the expression of LNK |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA expression levels of LNK
The expression level of LNK mRNA in the subcutaneous adipose tissue of the PCOS patients
Measured: 2 years
protein expression levels of LNK
The expression level of LNK protein in the subcutaneous adipose tissue of the PCOS patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start5 Nov 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, Study director, Sun Yat-sen Memorial Hospital, Sun Yat-sen Univers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146063
- Sponsor's protocol ID
- SYSEC-KY-KS-2021-187
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LNK Participates in Insulin Resistance in Polycystic Ovary Syndrome by Regulating Adipose Glucose Transport
- ClinicalTrials.gov ID
- NCT05146063
- Acronym / sponsor ID
- SYSEC-KY-KS-2021-187
- Conditions
- Polycystic Ovarian Syndrome, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with polycystic ovary syndrome who met the 2003 Rotterdam criteria were divided into insulin resistance group and non-insulin resistance group
Key inclusion criteria (1 listed)
- Patients with polycystic ovary syndrome who meet the 2003 Rotterdam criteria
Key exclusion criteria (1 listed)
- Do not meet the diagnostic criteria for polycystic ovary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take the patient's subcutaneous fat tissue to detect the expression of LNKTake the patient's subcutaneous fat tissue to detect the mRNA and protein expression levels of LNK by RT-qPCR and western blot. | Diagnostic test | Polycystic ovary syndrome patients with insulin resistance, Polycystic ovary syndrome patients without insulin resistance |
Primary outcome
mRNA expression levels of LNK
Time frame: 2 years
The expression level of LNK mRNA in the subcutaneous adipose tissue of the PCOS patients
protein expression levels of LNK
Time frame: 2 years
The expression level of LNK protein in the subcutaneous adipose tissue of the PCOS patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Zhang study director
Sun Yat-sen Memorial Hospital, Sun Yat-sen Univers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome and Insulin Resistance, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (+862081332120, sys_iit@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA expression levels of LNK (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.