Clinical trial NCT06066034: Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance
Official title: Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Keywords: PCOS
Insulin resistance
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sterile female

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.

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.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Polycystic Ovary Syndrome

Exclusion Criteria:

Congenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.

Primary outcomes:
measure: Serum LRG1 levels
timeFrame: one years
measure: follicular fluid LRG1 levels
timeFrame: one years
measure: Serum SREBP1c levels
timeFrame: one years
measure: follicular SREBP1c levels
timeFrame: one years
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
affiliation: Guizhou Provincial Health Commission
name: Fa Sun
role: PRINCIPAL_INVESTIGATOR
References: