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Completed

NCT Number: NCT05468476

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

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 .

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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

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

    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.

  2. Phenotype differences in the gut microbiome by metagenomic sequencing.

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

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

  1. BMI

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

    Body mass index (BMI)=weight(kg)/height(m)^2.

  2. TT

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

    total testosterone in nmol/L.

  3. LH

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

    luteinizing hormone in IU/L.

  4. FSH

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

    The follicle-stimulating hormone in IU/l.

  5. E2

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

    Estradiol in pmol/L.

  6. PRL

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

    Prolactin in uIU/ml.

  7. HC

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

    Hip Circumference in centimeters.

  8. WC

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

    Waist Circumference in centimeters.

  9. Waist/hip Ratio

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

    WHR=(Waist Circumference in centimeters)/(Hip Circumference in centimeters).

  10. Menstrual cycles

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

    the total number of menstrual periods in the last year.

  11. FBG

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

    fasting blood-glucose in mmol/L.

  12. PBG

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

    postprandial blood-glucose in mmol/L.

  13. FINS

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

    fasting serum insulin in mU/L.

  14. PINS

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

    postprandial insulin in mU/L.

  15. ALT

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

    alanine aminotransferase in U/L.

  16. AST

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

    aspartate aminotransferase in U/L.

  17. UA

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

    Uric acid in umol/L.

  18. CR

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

    Creatinine in umol/L.

  19. Ferriman-Gallwey score

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

    The minimum value of Ferriman-Gallwey score is 0 and the maximum value is 44. An Ferriman-Gallwey score greater than or equal to 6 is considered to be a clinical manifestation of androgen excess.

  20. HOMA-IR

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

    Homeostatic model assessment insulin resistance index=FBG*FINS/22.5.

  21. HbA1c (%)

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

    glycosylated hemoglobin (%).

  22. γ-GT

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

    γ-glutamyl transferase in U/L.

  23. BUN

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

    urea nitrogen in mmol/L.

  24. SOD

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

    Superoxide dismutase in pg/ml.

  25. Interleukin 22, IL-22

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

    Interleukin 22 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

  26. Interleukin 6，IL-6

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    Interleukin 6 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

  27. Interleukin 8， IL-8

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    Interleukin 8 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

  28. Tumor Necrosis Factor， TNF

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    Tumor Necrosis Factor in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.

  29. FT

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    free testosterone in nmol/L.

  30. DHEAS

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    Dehydroepiandrosterone Sulfate in ug/dl.

  31. SHBG

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    sex hormone-binding globulin in nmol/L.

  32. AD

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    Androstenedione in ng/ml.

  33. LDL-c

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    low-density lipoprotein cholesterol in mmol/L.

  34. HDL-c

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    high-density lipoprotein cholesterol in mmol/L.

  35. TC

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    Total Cholesterol in mmol/L.

  36. TG

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    Triglyceride in mmol/L.

  37. CRP

    Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

    C reactive protein in pg/ml.

Sponsors and collaborators

Lead sponsor

Zhang Manna

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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