Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
NCT Number: NCT06545721
Acronym: WHIP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome
Interventions: OTHER: Adjusting dietary structure + exercise + behavioral intervention
Sponsor: Peking Union Medical College Hospital
Sex: ALL
Age: ADULT
Enrollment: 425
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2026-08-15
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China

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.

Primary Outcome Measures: Weight loss rate, Percentage of weight loss: (Weight after reduction - Baseline weight before reduction) / Baseline weight before reduction (%), 6 month|Levels of insulin resistance, Measuring the level of insulin resistance in patients after the intervention., 6 month
Secondary Outcome Measures: Fasting insulin level（FINS）, Measure the fasting insulin levels of patients after the intervention., 6 month|Fasting blood sugar（FBG）, Measure the fasting blood glucose level of the patient after the intervention., 6 month|Blood levels of androgen hormones (total testosterone, free testosterone index), Measure the blood testosterone levels of the patients after the intervention., 6 month|Blood lipid levels (LDL-C, HDL-C, total cholesterol), Measure lipid levels in patients after the intervention., 6 month|Levels of inflammatory factors (CRP, IL-6, TAC, GSH), Detect the level of inflammatory factors in patients after intervention., 6 month|BMI, Measuring the BMI of patients after the intervention., 6 month|Waist, Measure the waist of the patients after the intervention., 6 month|waist-to-hip ratio, Measure the waist-to-hip ratio of the patients after the intervention., 6 month|Body fat percentage and distribution, Measure the Body Fat Content and Proportion in Patients after Intervention, 6 month|Weight rebound rate, Determine the rate of weight rebound in patients after intervention. Weight rebound is defined as a rebound in weight (≥5kg or 5% above baseline weight) after weight loss., 6 month