Polycystic Ovary Syndrome (PCOS)
Conditions
Brief summary
The goal of this clinical trial is to: 1. promote and optimize standardized diagnostic and treatment pathways for polycystic ovary syndrome (PCOS) and to investigate the clinical phenotypic characteristics of PCOS; 2. establish a bidirectional referral system and standardized referral pathways for PCOS; 3. comprehensively evaluate the effectiveness of standardized PCOS care pathways based on a bidirectional referral system; 4. collaborate with technical partners to develop an information-based clinical management platform for PCOS suitable for use in primary healthcare settings; and 5. investigate the effects of combined lifestyle intervention and prebiotic supplementation on insulin resistance and glucose-lipid metabolism in patients with PCOS. The main questions this study aims to answer are: 1. What are the clinical phenotypic characteristics of PCOS, and how effective are standardized diagnostic and treatment pathways for PCOS? 2. What are the effects of combined lifestyle intervention and prebiotic supplementation, implemented within standardized diagnostic and treatment pathways for PCOS, on insulin resistance and glucose-lipid metabolism in patients with PCOS? 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.
Interventions
DIETARY_SUPPLEMENTStandardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation
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.
BEHAVIORALStandardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention
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.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Female participants aged 18-50 years. 2. A diagnosis of PCOS based on the 2003 Rotterdam consensus, meeting at least two of the following three criteria: (i) oligo-ovulation and/or anovulation;(ii) clinical and/or biochemical signs of hyperandrogenism; or(iii) polycystic ovarian morphology on ultrasonography, defined as the presence of ≥12 follicles measuring 2-9 mm in diameter in each ovary and/or an ovarian volume ≥10 cm³.
Exclusion criteria
1. Patients with other serious medical conditions, including coronary heart disease (e.g., angina pectoris, myocardial infarction, history of coronary revascularization, or abnormal Q waves on electrocardiography), stroke (ischemic or hemorrhagic, including transient ischemic attack), or severe hepatic or renal dysfunction. 2. Patients with eating disorders or severe gastrointestinal diseases that may affect nutritional intervention outcomes. 3. Patients with any other medical condition associated with an estimated life expectancy of less than 5 years. 4. Patients with drug abuse, chronic alcoholism, alcohol dependence, or other addictive tendencies. 5. Patients who are unable to comply with dietary modification or lifestyle intervention or who are unlikely to adhere to follow-up visits. 6. Pregnant or lactating women, or those who have used oral contraceptives or glucagon-like peptide-1 (GLP-1) receptor agonists within the past 3 months. 7. Patients with a known allergy to prebiotics, those who have taken probiotics, prebiotics, or synbiotic supplements within the past 3 months, or those who have used antibiotics within the past 1 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical phenotypic characteristics of PCOS assessed by clinical evaluation | Baseline, Week 12, and Week 20 | 1. Improvement in PCOS clinical phenotypes based on the Rotterdam criteria Improvement in PCOS clinical phenotypes will be assessed by trained study investigators based on changes in clinical manifestations, including menstrual cycle regularity, clinical hyperandrogenism, and gynecological ultrasound findings. Overall improvement will be evaluated based on changes in phenotype-specific clinical characteristics according to the Rotterdam criteria. 2. Improvement in obesity-related metabolic phenotypes Improvement in obesity-related metabolic phenotypes will be assessed by trained study investigators based on changes in body weight status and metabolic health. Metabolic abnormality is defined as the presence of hypertension, impaired glucose metabolism, or dyslipidemia. Overall improvement will be evaluated based on changes in phenotype-specific characteristics related to body weight status and metabolic health. |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, Week 12, and Week 20 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Week 12, and Week 20 | 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. |
| 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 | — |
Countries
China
Contacts
STUDY_CHAIRShan Gao, Doctoral degree
Xuanwu Hospital, Beijing
Outcome results
None listed