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The goal of this clinical trial is to:
The main questions this study aims to answer are:
Researchers will compare standardized diagnostic and treatment pathways for PCOS before and after implementation to assess improvements in clinical outcomes in patients with PCOS, and will also compare lifestyle intervention with and without prebiotic supplementation to determine whether prebiotic supplementation can improve insulin resistance and glucos-lipid metabolism in patients with PCOS.
All participants will first undergo a 12-week run-in phase, during which standardized diagnostic and treatment pathways for PCOS combined with lifestyle intervention will be implemented uniformly. After completion of the run-in phase and randomization at Week 12, participants will be assigned to one of two parallel intervention arms. Participants in the control arm will continue to receive lifestyle intervention alone for an additional 8 weeks, without additional prebiotic supplementation. Participants in the intervention arm will continue to receive lifestyle intervention and will additionally receive prebiotic supplementation for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized PCOS Care + Lifestyle Intervention + Prebiotics | Experimental |
| |
| Standardized PCOS Care + Lifestyle Intervention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation | Dietary Supplement | Participants will first undergo the same 12-week run-in phase as the control arm, during which standardized diagnostic and treatment pathways for PCOS combined with lifestyle intervention will be implemented uniformly. After completion of the run-in phase and randomization at Week 12, participants in the intervention arm will continue to receive lifestyle intervention and will additionally receive prebiotic supplementation for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical phenotypic characteristics of PCOS assessed by clinical evaluation |
| Baseline, Week 12, and Week 20 |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Insulin resistance will be assessed using the HOMA-IR, calculated from fasting plasma glucose and fasting insulin levels measured at predefined study time points. Outcomes will include HOMA-IR values reported as continuous variables and comparisons of changes in HOMA-IR between baseline and post-intervention time points and/or between intervention groups. | Baseline, Week 12, and Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Baseline, Week 12, and Week 20 | |
| Body Mass Index | Baseline, Week 12, and Week 20 | |
| Menstrual cycle regularity assessed by menstrual cycle length and frequency |
| Measure | Description | Time Frame |
|---|---|---|
| Serum estradiol (E2) concentration | Serum E2 concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in estradiol concentrations will be compared between baseline and post-intervention time points and/or between intervention groups. | Baseline, Week 12, and Week 20 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shan Gao, Doctoral degree | Xuanwu Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | China |
Individual participant data will not be shared due to concerns regarding participant privacy and confidentiality, and because no formal plan for external data sharing has been established at this time.
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|
| Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention | Behavioral | Participants will first undergo a 12-week run-in phase, during which standardized diagnostic and treatment pathways for PCOS combined with lifestyle intervention will be implemented uniformly. After completion of the run-in phase and randomization at Week 12, participants in the control arm will continue to receive lifestyle intervention alone for an additional 8 weeks. |
|
Menstrual cycle regularity will be assessed by the study investigators based on menstrual cycle length and cycle frequency, obtained from patient-reported menstrual history during study visits. Menstrual irregularity is defined as a menstrual cycle length <21 or >35 days, or fewer than 8 menstrual cycles per year. |
| Baseline, Week 12, and Week 20 |
| Waist circumference | Baseline, Week 12, and Week 20 |
| Waist-to-hip ratio | Baseline, Week 12, and Week 20 |
| Blood pressure | Baseline, Week 12, and Week 20 |
| Fasting plasma glucose | Baseline, Week 12, and Week 20 |
| Fasting insulin | Baseline, Week 12, and Week 20 |
| Triglycerides | Baseline, Week 12, and Week 20 |
| Total cholesterol | Baseline, Week 12, and Week 20 |
| Low-density lipoprotein cholesterol | Baseline, Week 12, and Week 20 |
| High-density lipoprotein cholesterol | Baseline, Week 12, and Week 20 |
| Uric acid | Baseline, Week 12, and Week 20 |
| Serum progesterone concentration | Serum progesterone concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in progesterone concentrations will be compared between baseline and post-intervention time points and/or between intervention groups. | Baseline, Week 12, and Week 20 |
| Serum total testosterone (TT) concentration | Serum TT concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in total testosterone concentrations will be compared between baseline and post-intervention time points and/or between intervention groups. | Baseline, Week 12, and Week 20 |
| Serum luteinizing hormone (LH) concentration | LH concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in LH concentrations will be compared between baseline and post-intervention time points and/or between intervention groups. | Baseline, Week 12, and Week 20 |
| Serum follicle-stimulating hormone (FSH) concentration | Serum FSH concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in FSH concentrations will be compared between baseline and post-intervention time points and/or between intervention groups. | Baseline, Week 12, and Week 20 |
| Serum anti-Müllerian hormone (AMH) concentration | Serum anti-Müllerian hormone (AMH) concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. This outcome will be evaluated by trained study investigators. | Baseline, Week 12, and Week 20 |
| Gut microbiota composition assessed by 16S rRNA gene sequencing | Gut microbiota profiling will be conducted on fecal samples collected at predefined study time points using 16S rRNA gene sequencing. Outcomes will include measures of gut microbial diversity, relative abundances of bacterial taxa, and the identification of taxa showing significant changes between baseline and post-intervention time points and/or between intervention groups. These outcomes are intended to characterize intervention-associated alterations in gut microbiota composition. | Baseline and Week 20 |
| Circulating adipokines assessed by serum analysis | Adipokine profiling will be conducted on fasting serum samples collected at predefined study time points. Outcomes will include circulating concentrations of selected adipokines and the identification of adipokines showing significant changes between baseline and post-intervention time points and/or between intervention groups, reflecting alterations in adipose tissue-related endocrine function associated with the intervention. | Baseline, Week 12, and Week 20 |
| Serum proteomic profile assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) | Proteomic profiling will be conducted on fasting serum samples collected at predefined study time points using LC-MS/MS. Primary proteomic outcomes will include relative protein abundances quantified based on normalized signal intensities and the identification of proteins showing significant differential expression between baseline and post-intervention time points and/or between intervention groups, reflecting molecular alterations associated with the intervention. | Baseline, Week 12, and Week 20 |
| Serum metabolomic profile assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) | Metabolomic profiling will be conducted on fasting serum samples collected at predefined study time points using LC-MS/MS. Metabolomic outcomes will include relative abundances of detected metabolites quantified based on normalized signal intensities, as well as the identification of metabolites showing significant changes between baseline and post-intervention time points and/or between intervention groups, reflecting metabolic responses to the intervention. | Baseline, Week 12, and Week 20 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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