[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571074":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":46,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":46,"enrollmentInfo":80,"targetDuration":46,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":51,"whyStopped":46,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,13,19],{"label":9,"type":6,"description":10,"interventionNames":11},"Menopausal Hormone Therapy","Estradot®: 50 micrograms\u002F24h, transdermal patch E2;\n\nUtrogestan®\\*: once daily 200mg of micronized progesterone (in women with intact uterus\\*)",[12],"Drug: Menopausal Hormone Therapy",{"label":14,"type":15,"description":16,"interventionNames":17},"GLP-1 Receptor Agonist","ACTIVE_COMPARATOR","Wegovy®: Semaglutide injected once weekly, starting dose 0.25mg, with dose increments every four weeks reaching the maintenance dose of 1mg after eight weeks",[18],"Drug: GLP-1 Receptor Agonist",{"label":20,"type":21,"description":22,"interventionNames":23},"Combined Menopausal Hornome Therapy and GLP-1 Receptor Agonist","EXPERIMENTAL","Wegovy®: Semaglutide injected once weekly, starting dose 0.25mg, with dose increments every four weeks reaching the maintenance dose of 1mg after eight weeks; Estradot®: 50 micrograms\u002F24h, transdermal patch E2; Utrogestan®\\*: once daily 200mg of micronized progesterone (in women with intact uterus)",[18,12],[25,31],{"type":26,"name":14,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Wegovy®",[20,14],[30],"Semaglutide",{"type":26,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"Estradot® and Utrogestan®\\* (in women with intact uterus\\*)",[20,9],[35,36],"Estradiol","Micronized Progesterone",[38],{"name":39,"affiliation":40,"role":41},"Prof. Dr. med. et Dr. phil.Lia Bally","Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+41 31 632 36 77",null,"lia.bally@insel.ch",[49],{"facility":50,"status":51,"city":52,"state":46,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Hospital Bern","RECRUITING","Bern","3010","Switzerland","CH",{"type":57,"coordinates":58},"Point",[59,60],7.44744,46.94809,{"lat":60,"lon":59},[63],{"name":64,"role":44,"phone":65,"phoneExt":46,"email":47},"Prof. Dr. med. Dr. phil. Lia Bally","0041 31 63 2 36 77",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"SPONSOR_INVESTIGATOR","Lia Bally","Prof. Dr. med. et phil.","100571074","menopausal-hormone-therapy-glp-1-agonists-and-glucose-and-energy-homeostasis-in-postmenopausal-women-with-diabetes-100571074",false,"NCT06715514","Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes","Effects of Combined Menopausal Hormone Therapy and GLP-1 Receptor Agonist Therapy on Glucose and Energy Homeostasis in Early Postmenopausal Women With or at Risk of Diabetes","DECLARED-CT","Individuals fulfilling at enrolment all of the following inclusion criteria are eligible for the study:\n\n* Early postmenopausal status (STRAW+10 stage +1b or +1c and FSH\\>25.0mU\u002FL)\n* Presence of menopausal symptoms (total MRS-II score ≥1)\n* BMI ≥ 27.0kg\u002Fm2\n* Pre- or existing type 2 diabetes (HbA1c 5.7%-8.5%)\n* No prior or current use of MHT\n\nThe presence of any of the following exclusion criteria will lead to exclusion of the individuals:\n\n* DPP4-inhibitor, SLGT2-inhibitor or sulfonylurea use within 8 weeks prior to study enrolment\n* GLP-1RA use within 6 months prior to study enrolment\n* Insulin therapy within 8 weeks prior to study enrolment\n* History of bariatric surgery\n* More than 2% change in body weight within three months prior to study enrolment (based on documented or reported weights)\n* Contraindications for the use of the study medication as per prescription labelling: Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2\n* Known or suspected cancer of breast or other sexual organ, abnormal genital bleeding of unknown cause, hepatic neoplasia\n* Arterial or venous thromboembolic events, porphyria\n* Known allergy or hypersensitivity to Wegovy®, Estradot® or Utrogestan® (pharmaceutical agents or any of the excipients)\n* Systemic hormone therapy or hormonal contraceptives (e.g. estrogens, progestogens, androgens) during the study and within 12 months prior to participation\n* Herbal remedies and complimentary medicines for menopausal symptoms during the study\n* Physical or psychological condition or any medical intervention (including medication not specified above) likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator\n* Participation in another clinical trial that interferes with the interpretation of the study results\n* Inability to read German\n* Unwillingness to follow the study procedures","FEMALE","18 Years",{"count":81,"type":82},96,"ESTIMATED","INTERVENTIONAL",[85],"NA","The overall aim is to investigate the hypothesis that restoring E2 levels through MHT improves glucose and energy homeostasis and potentiates the beneficial effects of GLP-1RA in early postmenopausal women with pre- or existing type 2 diabetes.\n\nThe primary objective is to assess the efficacy of combined MHT and GLP-1RA in improving glucose control in early postmenopausal women with pre- or existing type 2 diabetes, compared to GLP-1RA alone. Secondary objectives include efficacy analyses on body weight, other measures of cardiometabolic health, lifestyle behaviour, menopausal symptoms, and the exploration of mechanisms underpinning potential glycaemic and weight control benefits, and biomarkers of haemostasis.",[88,89],"Menopause","Type 2 Diabetes",[91,88,9,92,93,94],"Diabetes","Womens Health","Randomized Controlled Trial","GLP-1 receptor agonist","2026-06-04",{"date":97,"type":98},"2026-06-05","ACTUAL",{"date":100,"type":98},"2025-02-18",{"date":102,"type":82},"2026-12-31",{"name":68,"class":6},1]