Status:
RECRUITING
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
All Genders
18-45 years
Phase:
NA
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 ...
Detailed Description
This study is a single-center, prospective cohort study that enrolled PCOS patients after screening. The patients were categorized into two groups based on their BMI: a normal weight group (18.5 kg/m2...
Eligibility Criteria
Inclusion
- Women aged 18-45 years in the reproductive period;
- 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;
- 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;
- Voluntarily participate in the intervention and sign an informed consent form.
Exclusion
- Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy;
- Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.);
- History of weight loss surgery;
- 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;
- Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc.;
- Known history of serious endocrine system diseases;
- Poor compliance with planned dietary interventions (psychiatric disorders such as binge eating disorder, anorexia nervosa, severe anxiety/depression);
- Unable to follow up on time or deemed non-cooperative by the investigator.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT06545721
Start Date
August 13 2024
End Date
April 1 2026
Last Update
December 3 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730