[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100350374":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":72,"centralContacts":79,"locations":88,"responsibleParty":105,"collaborators":107,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":10,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":10,"studyType":127,"phases":10,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",[8,21,25,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"I- Hypothalamic amenorrhea",null,"10 women with exercise-associated hypothalamic amenorrhea",[13,14,15,16,17,18,19,20],"Diagnostic Test: Anthropometric and physical examination","Diagnostic Test: Indirect calorimetry, accelerometer and seven-day dietary recall","Diagnostic Test: Biochemical, hormonal and metabolic phenotyping","Diagnostic Test: Sonographic studies","Diagnostic Test: 24-hour Ambulatory blood pressure monitoring","Procedure: Percutaneous biopsy","Diagnostic Test: Cardiovascular autonomic function studies","Diagnostic Test: Oral smear and feces specimen",{"label":22,"type":10,"description":23,"interventionNames":24},"II- Hyperandrogenic polycystic ovary syndrome","5 lean women with hyperandrogenic polycystic ovary syndrome. 5 women with weight excess and hyperandrogenic polycystic ovary syndrome.",[13,14,15,16,17,18,19,20],{"label":26,"type":10,"description":27,"interventionNames":28},"III- Non-hyperandrogenic polycystic ovary syndrome","5 lean women with non-hyperandrogenic polycystic ovary syndrome 5 women with weight excess and non-hyperandrogenic polycystic ovary syndrome",[13,14,15,16,17,18,19,20],{"label":30,"type":10,"description":31,"interventionNames":32},"IV- Trained women without ovulatory dysfunction","10 women who exercise as intensively as women with exercise-associated hypothalamic amenorrhea but with normal ovulatory cycles.",[13,14,15,16,17,18,19,20],{"label":34,"type":10,"description":35,"interventionNames":36},"V- Non-hyperandrogenic healthy women","10 women matched by age and body mass index with women with polycystic ovary syndrome who do not perform physical activity on a regular basis",[13,14,15,16,17,18,19,20],[38,43,47,51,55,59,64,68],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"DIAGNOSTIC_TEST","Anthropometric and physical examination","* Weight and height.\n* Waist-to-hip ratio.\n* Body composition: Bioelectrical impedance and \\[Dual energy X-ray absorptiometry (DEXA)\\].",[9,22,26,30,34],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"Indirect calorimetry, accelerometer and seven-day dietary recall","Energy availability assessment.",[9,22,26,30,34],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Biochemical, hormonal and metabolic phenotyping","* Lipid profile.\n* Oral glucose tolerance test: plasma glucose and insulin, insulin sensitivity indices, gastrointestinal hormones, adipokines, oxidative stress markers.\n* Sex steroid profile.\n* Hypothalamic-pituitary-adrenal axis study.\n* Ferrokinetic study.\n* Subclinical chronic inflammatory markers.",[9,22,26,30,34],{"type":39,"name":52,"description":53,"armGroupLabels":54,"otherNames":10},"Sonographic studies","* Polycystic ovarian morphology.\n* Carotid intima-media thickness.\n* Eco-FAT: Ultrasound measurements of adipose tissue depots including sc, preperitoneal, intraperitoneal (ip), mesenteric, and perirenal fat thickness.",[9,22,26,30,34],{"type":39,"name":56,"description":57,"armGroupLabels":58,"otherNames":10},"24-hour Ambulatory blood pressure monitoring","A\\&D TM2430EX oscillometric devices (A\\&D Company Limited, Tokyo, Japan).",[9,22,26,30,34],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":10},"PROCEDURE","Percutaneous biopsy","Subcutaneous fat tissue and muscle tissue for proteomics an gene expression studies.",[9,22,26,30,34],{"type":39,"name":65,"description":66,"armGroupLabels":67,"otherNames":10},"Cardiovascular autonomic function studies","Parasympathetic and sympathetic responses to deep breathing, Valsalva's maneuver and orthostatism.",[9,22,26,30,34],{"type":39,"name":69,"description":70,"armGroupLabels":71,"otherNames":10},"Oral smear and feces specimen","Microbiome studies.",[9,22,26,30,34],[73,77],{"name":74,"affiliation":75,"role":76},"Héctor F Escobar-Morreale, PhD, MD","Diabetes, Obesity and Human Reproduction Research Group (CIBERDEM), Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain","PRINCIPAL_INVESTIGATOR",{"name":78,"affiliation":75,"role":76},"Manuel Luque-Ramírez, PhD, MD",[80,85],{"name":81,"role":82,"phone":83,"phoneExt":10,"email":84},"Alejandra Quintero Tobar","CONTACT","34913369029","mariaalejandra.quintero@salud.madrid.org",{"name":86,"role":82,"phone":83,"phoneExt":10,"email":87},"Sara de Lope Quiñones","sara.lope@salud.madrid.org",[89],{"facility":90,"status":91,"city":92,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Endocrinology and Nutrition","RECRUITING","Madrid","28034","Spain","ES",{"type":97,"coordinates":98},"Point",[99,100],-3.70256,40.4165,{"lat":100,"lon":99},[103,104],{"name":81,"role":82,"phone":83,"phoneExt":10,"email":84},{"name":86,"role":82,"phone":83,"phoneExt":10,"email":87},{"type":106,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[108,111],{"name":109,"class":110},"Instituto de Salud Carlos III","OTHER_GOV",{"name":112,"class":6},"University of Alcala","100350374","body-fat-as-determinant-of-female-gonadal-dysfunction-100350374",false,"NCT03841981","Body Fat as Determinant of Female Gonadal Dysfunction","Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction: From Functional Hypothalamic Amenorrhea to the Polycystic Ovary Syndrome","Inclusion Criteria\n\nGroup I\n\n* Body mass index between 18.5 and 25.0 kg\u002Fm2.\n* Group 1 ovulatory dysfunction \\[World Health Organization (WHO) classification\\].\n* Normal\u002Flow gonadotrophin levels \\[follicle-stimulating hormone (FSH) and luteinizing (LH) \\\u003C 10 IU\u002Fl\\] and low estradiol (\\\u003C 50 pg\u002Fml).\n* Moderate-vigorous intensity physical activity (\\> 5 hours per week) plus low energy availability (\\\u003C 30 kcal\u002Fper kg of lean mass).\n* Exclusion of secondary etiologies\n* Informed consent signed.\n\nGroup II:\n\n* Polycystic ovary syndrome phenotype I, II and III \\[National Institute of Health (NIH)-2012\\] with hyperandrogenemia (http:\u002F\u002Fprevention.nih.gov\u002Fworkshops\u002F2012\u002Fresources.aspx).\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nGroup III:\n\n* Polycystic ovary syndrome phenotype IV (NIH-2012) (http:\u002F\u002Fprevention.nih.gov\u002Fworkshops\u002F2012\u002Fresources.aspx).\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nGroup IV:\n\n* Body mass index between 18.5 and 25.0 kg\u002Fm2.\n* Regular menses.\n* Normal gonadotropins and estradiol levels at follicular phase.\n* Moderate-vigorous intensity physical activity (\\> 5 hours per week) with normal energy availability (\\> 30 kcal\u002Fper kg of lean mass).\n* Informed consent signed.\n\nGroup V:\n\n* No signs or symptoms of hyperandrogenism.\n* No exercise or mild intensity physical activity.\n* Regular menses.\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nExclusion Criteria (Groups I-V)\n\n* Oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids and\u002For opioids) for the previous 6 months to study inclusion.\n* Current pregnancy or lactation, or during the previous 6 months to study inclusion.\n* Asherman's syndrome or outflow tract disorders.\n* Current smoking or alcohol intake \\> 40 g per day.\n* Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, known heart or lung diseases, kidney disease, liver disease, celiac disease or any other malabsorptive condition, chronic inflammatory disease or malignancy.",true,"FEMALE","18 Years","40 Years",{"count":125,"type":126},50,"ESTIMATED","OBSERVATIONAL","Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and\u002For function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be:\n\nPrimary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle.\n\nSecondary objectives:\n\n1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution.\n2. To study body composition and body fat distribution in these women and their relationships with:\n\n2.1, Sex steroid profiles.\n\n2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure.\n\n2.3 Markers of low-grade chronic inflammation.\n\n2.4. Oxidative stress markers.\n\n2.5. Cardiovascular autonomic function.\n\n2.6. Surrogate markers of subclinical atherosclerosis.\n\n2.7. Circulating concentrations of endocrine disruptors.\n\n2.8. Oral and gut microbiome.\n\nThe results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.",[130,131],"Polycystic Ovary Syndrome","Hypothalamic Amenorrhea",[133,134,135,136,137,138,139,140,141,142],"Exercise","Sex steroids","Hyperandrogenism","Adipose tissue","Muscle","Proteome","Gene expression","Adipokine","Cardiovascular risk","Microbiome","2025-08-06",{"date":145,"type":146},"2025-08-12","ACTUAL",{"date":148,"type":146},"2020-01-31",{"date":150,"type":126},"2025-12-31",{"name":5,"class":6},1]