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Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome

RecruitingNAAges 18 Years - 45 YearsAllPeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

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 expl

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📋 Eligibility rules (as published)
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.
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What it tests

  • Adjusting dietary structure + exercise + behavioral intervention
  • Precision dietary prescription
  • Standard guideline-based low-energy diet
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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