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

Sponsor
Gui Xiaoting (Other)
Overall Status
Recruiting
CT.gov ID
NCT06066034
Collaborator
(none)
200
1
25
8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HOMA-IR,ESHRE/ASRM

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Serum LRG1 levels [one years]

    pg/ml

  2. follicular fluid LRG1 levels [one years]

    pg/ml

  3. Serum SREBP1c levels [one years]

    pmol/mL

  4. follicular SREBP1c levels [one years]

    pmol/mL

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Clinical diagnosis of Polycystic Ovary Syndrome

Exclusion Criteria:

Congenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Zunyi Medical University Zunyi Guizhou China 563000

Sponsors and Collaborators

  • Gui Xiaoting

Investigators

  • Principal Investigator: Fa Sun, Guizhou Provincial Health Commission

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gui Xiaoting, Resident physician, Zunyi Medical College
ClinicalTrials.gov Identifier:
NCT06066034
Other Study ID Numbers:
  • KLLY-2022-041
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gui Xiaoting, Resident physician, Zunyi Medical College
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023