Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT06545721

Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome

Led by Peking Union Medical College Hospital · Updated on 2025-12-03

425

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45 years in reproductive age
  • Diagnosis of PCOS by Rotterdam criteria (at least 2 of: irregular ovulation, signs of high androgens, or polycystic ovaries on ultrasound)
  • Normal weight group: BMI between 18.5 and less than 24 kg/m2 (50 women)
  • Overweight/obese group: BMI 24 kg/m2 or higher (400 women)
  • Willing to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Currently pregnant, breastfeeding, or planning pregnancy within 6 months
  • Using prescription weight loss drugs like GLP-1RA, orlistat, or topiramate
  • History of weight loss surgery
  • Severe heart, brain, liver, kidney, gastrointestinal, systemic diseases, or active cancers
  • Secondary obesity from causes like hypothalamic or pituitary disorders, glucocorticoid use, or hypogonadism
  • Serious endocrine system diseases
  • Poor compliance due to psychiatric disorders such as binge eating, anorexia, or severe anxiety/depression
  • Unable to attend follow-ups or considered non-cooperative by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

W

Wei Chen, PhD

CONTACT

M

Menglu Zhang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

4

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