Clinical trial · Observational
Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls
NCT05468476CI-TRIAL-00066073completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Other: No intervention
- label
- 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.
- interventionNames
- Other: No intervention
Primary outcomes (4)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.