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

NCT ID: NCT05468476

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-12-31

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).

Conditions

Polycystic Ovary Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with PCOS (PCOS group)

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.

No intervention

Intervention Type: OTHER

No intervention

Women without PCOS (Non-PCOS group)

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.

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhang Manna

OTHER

Sponsor Role: lead

Responsible Party

Zhang Manna

Director, Principal Investigator, Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Manna Zhang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Shanghai Tenth People's Hospital

Locations

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

Multi-omics PCOS

Identifier Type: -

Identifier Source: org_study_id