Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome (NCT06545721) | Clinical Trial Compass
RecruitingNot Applicable
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
China425 participantsStarted 2024-08-13
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.