Clinical trial NCT05468476: Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls
Official title: Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: Gut microbiome
metabolomics
transcriptomic
obesity
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study enrolled 63 PCOS women with obesity and 58 age- and body mass index (BMI)-matched subjects with normal menstrual cycles who were admitted to the Department of Endocrinology, Shanghai Tenth People's Hospital, between April 2019 and November 2022.

Brief summary: Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in reproductive-aged women， which associated with increased risks to develop metabolic disorders, including cardiovascular diseases, diabetes mellitus, and cerebrovascular diseases. The precise pathogenesis of PCOS remains unknown but is thought to be multifactorial, comprising genetic and environmental factors .

Detailed description: To study the pathogenesis of diseases, the study of multi-omics approach has been applied in various diseases researching . Obesity and PCOS are both metabolic disorders, and both have an impact on metagenomics, metabolomics and transcriptome. Currently, multi-omics studies based on obese PCOS are still limited. Therefore, this study tried to use a multi-omics approach that integrates the gut microbiome, serum metabolomics, serum transcriptomics, and clinical indicators to distinguish obese PCOS from obese non-PCOS women. To investigate whether the specific composition of the gut microbiome is associated with PCOS in obese women. Serum metabolomics and transcriptomics were analyzed to explore potential metabolic pathways. Meanwhile, gut microbiome and serum metabolomics are used to predict the occurrence of PCOS. Then, a new metabolite that could predict PCOS were tested on female mice with high fat diet (HFD).

Eligibility criteria: Inclusion Criteria:

* patients with obesity (BMI\>28kg/m2)
* aged 18-45 years
* Diagnosis of PCOS
* the Rotterdam diagnosis criteria (2003)

Exclusion Criteria:

* Pregnant women;
* Hyperthyroidism or hypothyroidism
* Severe liver and kidney function injury
* Cancer patients;
* Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
* Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
* Patients with mental illness or intellectual disability;
* Have taken drugs for PCOS treatment in the last three months;
* Taking drugs or foods (antibiotics, probiotics, yogurt, etc.) that affect the intestinal flora for nearly one month;
* Have a long history of taking hormone therapy;
* Currently or recently participating in another clinical trial.

Primary outcomes:
measure: Phenotype differences in the Serum non-targeted metabolomics by LC-MS.
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: Phenotype differences in the gut microbiome by metagenomic sequencing.
timeFrame: Samples to be collected once per participant within 7 days of enrollment
measure: Phenotype differences in the transcriptome expression by mRNA-seq.
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: Phenotype differences in the Serum targeted metabolomics by LC-MS.
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
Secondary outcomes:
measure: BMI
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: TT
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: LH
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: FSH
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: E2
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: PRL
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: HC
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: WC
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: Waist/hip Ratio
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: Menstrual cycles
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: FBG
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: PBG
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: FINS
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: PINS
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: ALT
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: AST
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: UA
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: CR
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: Ferriman-Gallwey score
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: HOMA-IR
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: HbA1c (%)
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: γ-GT
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: BUN
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: SOD
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: Interleukin 22, IL-22
timeFrame: Samples to be collected once per participant within 7 days of enrollment.
measure: Interleukin 6，IL-6
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: Interleukin 8， IL-8
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: Tumor Necrosis Factor， TNF
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: FT
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: DHEAS
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: SHBG
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: AD
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: LDL-c
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: HDL-c
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: TC
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: TG
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
measure: CRP
timeFrame: Blood samples to be collected once per participant within 7 days of enrollment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Department of Endocrinology, Shanghai Tenth People's Hospital
name: Manna Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: