NCT06545721 Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
| NCT ID | NCT06545721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Polycystic Ovary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 425 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 425 participants in total. It began in 2024-08-13 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study prospectively includes PCOS patients with normal weight and overweight/obesity, closely follows up and intensively manages them, and observes the level and distribution of weight reduction achieved by patients after lifestyle intervention (high-protein diet for weight loss). Additionally, it aims to provide reference for setting weight loss targets for future PCOS patients by comparing the differences in clinical improvement among patients achieving different degrees of weight reduction (\<2% \[equivalent to no weight loss\], 2-5%, 5-10%, ≥10%) at different time points (3 months, 6 months) following dietary intervention. Furthermore, this study will compare the differences in reproductive and metabolic marker improvements between baseline PCOS patients experiencing weight rebound, those who successfully lost weight, and those who experienced weight rebound. This will help explore the impact of weight cycling on PCOS-related manifestations. Finally, at a genetic level, the study will analyze potential mechanisms underlying different outcome indicators by comparing differences in metagenomics, transcriptomics, and metabolomics among patient groups. Ancillary/Nested Sub-study (12-week Precision Nutrition Trial): Within the WHIP cohort, we will conduct a nested, prospective interventional sub-study to evaluate the efficacy of an insulin-resistance-phenotype-guided precision dietary prescription versus a standard guideline-based energy-restricted diet. Eligible participants are women with PCOS and insulin resistance enrolled in the cohort. The sub-study lasts 12 weeks with assessments at baseline and week 12. Primary endpoints include change in HOMA-IR and change in the core11 metabolic risk composite. Secondary endpoints include changes in gonadotropins (FSH, LH), sex steroid hormones (e.g., estradiol, progesterone), and patient-reported symptom scores.
Eligibility Criteria
Inclusion Criteria: 1. Women aged 18-45 years in the reproductive period; 2. Women who have previously met the Rotterdam diagnostic criteria (at least 2 of the following 3 criteria have been confirmed, and have been diagnosed with PCOS): 1) Oligomenorrhea and/or anovulation; 2) clinical and/or biochemical evidence of hyperandrogenism; 3) ultrasound showing the presence of unilateral or bilateral polycystic ovaries; 3. Inclusion of 50 women in the normal weight group: 18.5 kg/m² ≤ BMI \< 24 kg/m²; Inclusion of 400 women in the overweight/obese group: BMI ≥ 24 kg/m²; 4. Voluntarily participate in the intervention and sign an informed consent form. Exclusion Criteria: 1. Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy; 2. Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.); 3. History of weight loss surgery; 4. History of severe cardiovascular or cerebrovascular diseases; severe liver or kidney dysfunction (ALT \> 3 times the upper limit of normal, or creatinine \> 1.5 times the upper limit of normal); chronic or active gastrointestinal inflammatory diseases; severe systemic diseases; active malignant tumors; 5. Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc.; 6. Known history of serious endocrine system diseases; 7. Poor compliance with planned dietary interventions (psychiatric disorders such as binge eating disorder, anorexia nervosa, severe anxiety/depression); 8. Unable to follow up on time or deemed non-cooperative by the investigator.
Contact & Investigator
Wei Chen, PhD
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT06545721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Polycystic Ovary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545721 currently recruiting?
Yes, NCT06545721 is actively recruiting participants. Contact the research team at txchenwei@sina.com for enrollment information.
Where is the NCT06545721 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06545721 clinical trial?
NCT06545721 is sponsored by Peking Union Medical College Hospital. The principal investigator is Wei Chen, PhD at Peking Union Medical College Hospital. The trial plans to enroll 425 participants.