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

NCT05468476 | Completed

• 1 other identifier: Multi-omics PCOS
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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 .

Conditions

Polycystic Ovary Syndrome

Keywords

Gut microbiome; metabolomics; transcriptomic; obesity

Outcome Measures

Primary Outcomes (4)

• Phenotype differences in the Serum non-targeted metabolomics by LC-MS.

  Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze non-target metabolites.

  Samples to be collected once per participant within 7 days of enrollment.

• Phenotype differences in the gut microbiome by metagenomic sequencing.

  Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.

  Samples to be collected once per participant within 7 days of enrollment

• Phenotype differences in the transcriptome expression by mRNA-seq.

  Understand phenotypical differences from biological samples comparing women with and without PCOS. The researcher will collect and analyze Venipuncture blood for RNA. Differences in the expression of genes between the two groups of subjects, analysis to select possible pathogenic factors leading to the pathogenesis of PCOS.

  Samples to be collected once per participant within 7 days of enrollment.

• Phenotype differences in the Serum targeted metabolomics by LC-MS.

  Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze the target metabolite.

  Samples to be collected once per participant within 7 days of enrollment.

Secondary Outcomes (37)

• BMI

  Samples to be collected once per participant within 7 days of enrollment.

• TT

  Samples to be collected once per participant within 7 days of enrollment.

• LH

  Samples to be collected once per participant within 7 days of enrollment.

• FSH

  Samples to be collected once per participant within 7 days of enrollment.

• E2

  Samples to be collected once per participant within 7 days of enrollment.

Study Arms (2)

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.

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Women with PCOS (PCOS group); Women without PCOS (Non-PCOS group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhang Manna: lead

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Metabolome Serum Sample Collection，Transcriptome RNA sample collection and Stool specimen collection

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manna Zhang, Ph.D

  Department of Endocrinology, Shanghai Tenth People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: July 21, 2022
• Study Start: May 1, 2019
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)