Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls

Zhang Manna

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05468476

Multi-omics PCOS

Details and patient eligibility

About

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 .

Full 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).

Enrollment: 121 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

121 participants in 2 patient groups

Women with PCOS (PCOS group)

Description:

PCOS women with obesity previously diagnosed with PCOS（meet the 2003 Rotterdam diagnostic criteria） not using hormonal therapy and without other significant health or endocrine issues.

Treatment:

Other: No intervention

Women without PCOS (Non-PCOS group)

Description:

This study enrolled age- and body mass index (BMI)-matched subjects with normal menstrual cycles, not using hormonal therapy, and without any significant health or endocrine issues.

Treatment:

Other: No intervention