Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance

September 29, 2023 updated by: Gui Xiaoting
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. Due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has increased. Its clinical manifestations are heterogeneous, with typical clinical manifestations being oligomenorrhea or amenorrhea, infertility, hirsutism, and polycystic ovarian changes under ultrasound. Women affected by PCOS face significant reproductive challenges, seriously affecting their quality of life and increasing their psychological burden.LRG1 has various regulatory functions, including glucose and lipid metabolism, IR, angiogenesis, organ fibrosis, and inflammation. LRG1 can activate the transcription factor SREBP1 and participate in liver lipid synthesis in obese mice. SREBP1c is the active form of SREBP1. Research has shown that SREBP1c can directly or indirectly participate in the development of IR. Therefore, the investigators speculate that LRG1 may play a certain role in the progression of PCOS through SREBP1c.Understanding the local changes or metabolic characteristics of follicular fluid in patients with PCOS can help elucidate the pathogenesis of PCOS. Therefore, in this study,the investigators aim to detect changes in serum and follicular fluid LRG1, SREBP1c, and related hormone levels, and explore their role in the pathogenesis of PCOS from a systemic and ovarian perspective, providing new ideas for the prevention and treatment of PCOS and IR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. The diagnostic criteria for all participants with polycystic ovary syndrome included in the study were based on the 2003 European Society for Human Reproductive and Embryonic Medicine and American Society for Reproductive Medicine (ESHRE/ASRM) diagnostic criteria in Rotterdam.
  2. Collect basic data of all participants.
  3. After informed consent, all participants were evaluated for insulin sensitivity(the degree of insulin resistance), using the insulin resistance index of the steady-state model. All participants were conducted after signing an informed consent form.
  4. After informed consent, all participants were given fasting venous blood samples in the morning for measuring blood sugar, blood lipids, insulin, C-peptide, glycosylated hemoglobin (HbA1c), and a complete set of sex hormones.
  5. After collecting follicular fluid from all participants, centrifuge at 1000xg for 20 minutes, filter and precipitate, and freeze in a refrigerator at -80 ° C for the determination of LRG1, SREBP1c, and related hormone levels in follicular fluid.
  6. Use SPSS 22.0 statistical software for data analysis.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital Of Zunyi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Sterile female

Description

Inclusion Criteria:

Clinical diagnosis of Polycystic Ovary Syndrome

Exclusion Criteria:

Congenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal group
With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle
Insulin resistance group
With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle
Diagnostic test: HOMA-IR，ESHRE/ASRM
Grouping based on HOMA-IR and the diagnostic criteria of the European Society for Human Reproduction and Embryology and American Society for Reproductive Medicine (ESHRE/ASRM) in Rotterdam in 2003
PCOS group
With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle
Diagnostic test: HOMA-IR，ESHRE/ASRM
Grouping based on HOMA-IR and the diagnostic criteria of the European Society for Human Reproduction and Embryology and American Society for Reproductive Medicine (ESHRE/ASRM) in Rotterdam in 2003
PCOS with insulin resistance group
With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle
Diagnostic test: HOMA-IR，ESHRE/ASRM
Grouping based on HOMA-IR and the diagnostic criteria of the European Society for Human Reproduction and Embryology and American Society for Reproductive Medicine (ESHRE/ASRM) in Rotterdam in 2003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum LRG1 levels
Time Frame: one years
pg/ml
one years
follicular fluid LRG1 levels
Time Frame: one years
pg/ml
one years
Serum SREBP1c levels
Time Frame: one years
pmol/mL
one years
follicular SREBP1c levels
Time Frame: one years
pmol/mL
one years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gui Xiaoting

Investigators

  • Principal Investigator: Fa Sun, Guizhou Provincial Health Commission

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLLY-2022-041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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