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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
227
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.
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.
Xuanwu Hospital, Capital Medical University
Beijing, China
Clinical phenotypic characteristics of PCOS assessed by clinical evaluation
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.
Time frame: 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.
Time frame: Baseline, Week 12, and Week 20
Weight
Time frame: Baseline, Week 12, and Week 20
Body Mass Index
Time frame: Baseline, Week 12, and Week 20
Menstrual cycle regularity assessed by menstrual cycle length and frequency
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.
Time frame: Baseline, Week 12, and Week 20
Waist circumference
Time frame: Baseline, Week 12, and Week 20
Waist-to-hip ratio
Time frame: Baseline, Week 12, and Week 20
Blood pressure
Time frame: Baseline, Week 12, and Week 20
Fasting plasma glucose
Time frame: Baseline, Week 12, and Week 20
Fasting insulin
Time frame: Baseline, Week 12, and Week 20
Triglycerides
Time frame: Baseline, Week 12, and Week 20
Total cholesterol
Time frame: Baseline, Week 12, and Week 20
Low-density lipoprotein cholesterol
Time frame: Baseline, Week 12, and Week 20
High-density lipoprotein cholesterol
Time frame: Baseline, Week 12, and Week 20
Uric acid
Time frame: Baseline, Week 12, and Week 20
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