Effects of weight loss and weight regain on androgen levels and insulin resistance in PCOS.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective cohort enrolling about 425 women with PCOS split into a normal-weight group and an overweight/obese group. Overweight/obese participants receive an intensive high-protein diet plus exercise and behavioral interventions for weight loss, while normal-weight participants receive energy-control and behavior support to prevent weight gain. Participants are followed at 3 and 6 months and categorized by percent weight change (<2%, 2–5%, 5–10%, ≥10%) to compare changes in insulin resistance, androgen levels, and inflammatory markers. The study also includes genetic/transcriptome analyses to explore molecular mechanisms linking weight change and weight cycling to PCOS manifestations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Wei Chen, PhD — Peking Union Medical College Hospital
• Study coordinator: Wei Chen, PhD
• Email: txchenwei@sina.com
• Phone: 13911006820

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.