[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558023":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":48,"locations":57,"responsibleParty":74,"collaborators":34,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":34,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":59,"whyStopped":34,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal weight group","EXPERIMENTAL","18.5 kg\u002Fm2 ≤ BMI \\\u003C 24 kg\u002Fm2",[13],"Other: Adjusting dietary structure + exercise + behavioral intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Obese\u002FOverweight Group","BMI ≥24 kg\u002Fm²",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Precision dietary prescription (nested substudy)","Within the WHIP cohort, participants with PCOS and insulin resistance who enroll in the ancillary 12-week pragmatic intervention will receive a precision dietary prescription tailored to their baseline insulin-resistance metabolic subphenotype. The prescription includes an individualized daily energy deficit according to the Chinese guideline for medical nutrition therapy in overweight\u002Fobesity, personalized macronutrient distribution, and food-based meal plans. Participants receive dietitian counseling at baseline and scheduled follow-ups throughout the 12-week period, in addition to standard lifestyle advice provided in the parent cohort.",[22],"Behavioral: Precision dietary prescription",{"label":24,"type":25,"description":26,"interventionNames":27},"Standard guideline-based low-energy diet (nested substudy control)","ACTIVE_COMPARATOR","Within the WHIP cohort, participants with PCOS and insulin resistance who enroll in the ancillary 12-week pragmatic intervention will receive a uniform low-energy diet based on standard guideline recommendations. The daily energy deficit is set according to the Chinese guideline for medical nutrition therapy in overweight\u002Fobesity, without tailoring to metabolic subphenotype. Contact frequency and follow-up intensity are comparable to the precision-diet arm, and standard lifestyle advice is provided throughout the 12-week period.",[28],"Behavioral: Standard guideline-based low-energy diet",[30,35,40],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Adjusting dietary structure + exercise + behavioral intervention","Adjusting to a healthy diet involves consuming low GI and low-fat foods, avoiding sugary drinks, increasing dietary fiber intake, reducing saturated fat while increasing omega-3 unsaturated fat intake, and limiting trans fat consumption. A weight loss program includes a high-protein diet, exercise, and behavioral intervention with daily total energy needs calculated based on ideal body weight (kg) x 15-20 kcal\u002Fkg\u002Fd; developing a daily meal plan with regular protein supplementation; limiting salt intake to ≤5 g\u002Fd; ensuring adequate water consumption at 2-3L\u002Fd; aiming for a dietary fiber intake of 25-30g\u002Fd; recommending micronutrient supplementation as needed; maintaining daily aerobic exercise (40 minutes at 70-80% HRmax) along with resistance training (20 minutes); establishing an early bedtime before 11pm and an early wake-up time.",[9,15],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"BEHAVIORAL","Precision dietary prescription","A 12-week precision diet program individualized to baseline insulin-resistance metabolic subphenotype, including personalized macronutrient targets, food-based meal plans, and dietitian-led counseling with regular follow-ups.",[19],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"Standard guideline-based low-energy diet","A 12-week standardized low-energy diet based on national guideline recommendations for overweight\u002Fobesity, with the same counseling frequency as the precision-diet arm but without metabolic tailoring.",[24],[45],{"name":46,"affiliation":5,"role":47},"Wei Chen, PhD","PRINCIPAL_INVESTIGATOR",[49,53],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":52},"CONTACT","13911006820","txchenwei@sina.com",{"name":54,"role":50,"phone":55,"phoneExt":34,"email":56},"Menglu Zhang, PhD","13051336015","499527281@qq.com",[58],{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":66,"coordinates":67},"Point",[68,69],116.39723,39.9075,{"lat":69,"lon":68},[72,73],{"name":46,"role":50,"phone":51,"phoneExt":34,"email":52},{"name":54,"role":50,"phone":55,"phoneExt":34,"email":56},{"type":47,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Wei Chen","Professor","100558023","weight-cycling-on-hyperandrogenemia-and-insulin-resistance-in-polycystic-ovary-syndrome-100558023",false,"NCT06545721","Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome","The Effect and Mechanism Of Weight Cycling on Hyperandrogenemia And Insulin Resistance in Polycystic Ovary Syndrome","WHIP","Inclusion Criteria:\n\n1. Women aged 18-45 years in the reproductive period;\n2. 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\u002For anovulation; 2) clinical and\u002For biochemical evidence of hyperandrogenism; 3) ultrasound showing the presence of unilateral or bilateral polycystic ovaries;\n3. Inclusion of 50 women in the normal weight group: 18.5 kg\u002Fm² ≤ BMI \\\u003C 24 kg\u002Fm²; Inclusion of 400 women in the overweight\u002Fobese group: BMI ≥ 24 kg\u002Fm²;\n4. Voluntarily participate in the intervention and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy;\n2. Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.);\n3. History of weight loss surgery;\n4. 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;\n5. Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc.;\n6. Known history of serious endocrine system diseases;\n7. Poor compliance with planned dietary interventions (psychiatric disorders such as binge eating disorder, anorexia nervosa, severe anxiety\u002Fdepression);\n8. Unable to follow up on time or deemed non-cooperative by the investigator.","ALL","18 Years","45 Years",{"count":89,"type":90},425,"ESTIMATED","INTERVENTIONAL",[93],"NA","This study prospectively includes PCOS patients with normal weight and overweight\u002Fobesity, 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 (\\\u003C2% \\[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.\n\nAncillary\u002FNested Sub-study (12-week Precision Nutrition Trial):\n\nWithin 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.",[96],"Polycystic Ovary Syndrome",[98,99,100,101,102,103,104],"Weight Cycling","Hyperandrogenemia","Insulin Resistance","High-protein diet","Transcriptome","Metabolome","Inflammatory status","2025-11-25",{"date":107,"type":108},"2025-12-03","ACTUAL",{"date":110,"type":108},"2024-08-13",{"date":112,"type":90},"2026-04-01",{"name":5,"class":6},1]