[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06490146":3,"trial-entities:NCT06490146":105,"trial-summary:NCT06490146":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":44,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":79,"locations":81,"central_contacts":95,"overall_officials":99,"references":103,"see_also_links":104},"NCT06490146","PT-2024-32769","Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function","RECRUITING","2030-08-21","2026-05","2026-05-20","2025-04-01","University of Minnesota","OTHER",null,"This is a longitudinal study to determine the influence of the menopause transition on autonomic and vascular function. PI Keller-Ross has published data demonstrating that postmenopausal females have greater sympathetic neural reactivity during a stressor compared with age-matched males and younger females and males. A paucity of literature exists, however, on the role of the menopause transition in autonomic function because the majority of experimental studies on menopause physiology are cross-sectional and\u002For focused on older, postmenopausal females .\n\nThe influence of age on HTN is robust, whereas the effects of menopause are still unclear. Preliminary data demonstrate a clear association between age and sympathetic activity in females; how the transition through menopause influences these relations, however, remains unknown. The study will enroll 80 midlife (45-55 years of age) females to measure longitudinally the trajectory of autonomic and vascular function during the transition through menopause. The study hypothesizes that through the menopause transition, an increase in sympathetic activity and an impaired baroreflex sensitivity and endothelial function will emerge.",[17],"Menopause",[19,20,21],"blood pressure","perimenopause","vascular","OBSERVATIONAL",[],{"count":25,"type":26},100,"ESTIMATED",[28],{"type":13,"name":29,"description":30,"armGroupLabels":31},"No intervention","this is an observational study",[32],"Study group",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"MSNA- Burst frequency","measured in bursts\u002Fmin\n\nMicroneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity\n\nParticipants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.","up to 5 years",{"measure":39,"description":40,"timeFrame":37},"MSNA- Burst incidence","measured in bursts\u002F100 heartbeats\n\nMicroneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity\n\nParticipants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.",{"measure":42,"description":43,"timeFrame":37},"MSNA- total activity","Microneurography to measure MSNA: Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves. A tungsten microelectrode is placed in a peripheral nerve (Figure 8) to record real-time activity from efferent sympathetic vasoconstrictor nerve fibers. MSNA is the gold-standard measure for sympathetic activity\n\nParticipants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.",[45,48,51],{"measure":46,"description":47,"timeFrame":37},"cardiovagal baroreflex sensitivity: ms\u002FmmHg","Cardiovagal baroreflex is estimated by responses in the R-R interval of the ECG to changes in systolic pressure.\n\nParticipants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.",{"measure":49,"description":50,"timeFrame":37},"sympathetic baroreflex sensitivity: bursts\u002F100heartbeats\u002FmmHg","Sympathetic baroreflex is estimated by responses in MSNA to changes in diastolic pressure.\n\nParticipants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.",{"measure":52,"description":53,"timeFrame":37},"vascular conductance (mL\u002F100mL tissue\u002Fmin\u002FmmHg)","vascular conductance via venous occlusion plethysmography will be quantified by FBF\u002Fmean arterial pressure\n\nParticipants attend experimental visits annually until they enter perimenopause, at which point they will attend such visits every six months.","FEMALE","45 Years","55 Years",true,{"inclusion":59,"exclusion":67,"raw_text":78},[60,61,62,63,64,65,66],"Female","age 45-55 years","premenopausal","not using any medications determined to affect autonomic function","eumenorrheic","not planning to become pregnant for the duration of participation in the study","English-speaking, literate, willing and able to provide informed consent.",[68,69,70,71,72,73,74,75,76,77],"Diabetes","pregnant or breastfeeding","cardiac or pulmonary disorders","severe obesity (body mass index \\[BMI\\] ≥ 40 kg\u002Fm 2 )","hypertension","obstructive sleep apnea","current use of heart or blood pressure medications, current use of hormonal contraceptives or other forms of exogenous sex hormones","report of nicotine\u002Ftobacco use in the last six months, report of current alcohol abuse,","history of treatment with chemotherapy\u002Fradiation","coagulopathy disorders and\u002For use of anticoagulant medications, and current use of anxiolytics and\u002For antidepressants.","Inclusion Criteria:\n\n* Female\n* age 45-55 years\n* premenopausal\n* not using any medications determined to affect autonomic function\n* eumenorrheic\n* not planning to become pregnant for the duration of participation in the study\n* English-speaking, literate, willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Diabetes\n* pregnant or breastfeeding\n* cardiac or pulmonary disorders\n* severe obesity (body mass index \\[BMI\\] ≥ 40 kg\u002Fm 2 )\n* hypertension\n* obstructive sleep apnea\n* current use of heart or blood pressure medications, current use of hormonal contraceptives or other forms of exogenous sex hormones\n* report of nicotine\u002Ftobacco use in the last six months, report of current alcohol abuse,\n* history of treatment with chemotherapy\u002Fradiation\n* coagulopathy disorders and\u002For use of anticoagulant medications, and current use of anxiolytics and\u002For antidepressants.",[80],"ADULT",[82],{"facility":12,"status":7,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":92},"Minneapolis","Minnesota","55414","United States",[88],{"name":89,"role":90,"email":91},"Emma Lee","CONTACT","menopause@umn.edu",{"lat":93,"lon":94},44.97997,-93.26384,[96],{"name":97,"role":90,"phone":98,"email":91},"Emma Lee, PhD","612-301-8617",[100],{"name":101,"affiliation":12,"role":102},"Manda Keller-Ross","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Menopause present",[],{"nct_id":4,"found":57,"summary":110,"prompt_version":119},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":25,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an observational study, meaning there are no interventions or treatments. It plans to enroll 100 participants.","completed","Menopause Transition and Vascular Function Study","This study is looking at how the menopause transition affects your body's automatic functions (like heart rate and blood pressure) and blood vessel health. Researchers want to understand why women after menopause might have different responses to stress compared to men or younger women. This is an observational study, meaning there are no interventions or treatments being tested. We are looking for women aged 45-55 who are premenopausal and not taking medications that affect automatic body functions. The study will measure nerve activity related to blood pressure over up to 5 years to see how these changes occur during menopause.","Participants will be followed for up to 5 years to measure nerve activity.","Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]