- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07621965
The Bone and hEArt Health Consequences of Ovarian agiNg (BEACON) Study (BEACON)
27. maj 2026 opdateret af: David Haas, Indiana University
Ovarian aging is a major driver of a woman's long-term health and disease risk.
In particular, the rapid decline in the ovarian reserve that occurs with the menopause transition is linked to a striking increase in the risk for both cardiometabolic disease and osteoporosis.
A growing body of evidence has demonstrated that earlier age at menopause further exacerbates this risk for ischemic stroke, heart disease, and non-traumatic osteoporotic fracture.
Thus, the identification of factors that accelerate ovarian aging is likely to lead to increased incidence and earlier onset of these conditions.
Adverse pregnancy outcomes (APO) such as gestational diabetes, hypertensive disorders of pregnancy, and stillbirth, are major pathophysiological states that have the potential to accelerate depletion of the ovarian reserve due to the chronic inflammatory state, oxidative stress, and epigenetics changes that ensue.
This proposal seeks to determine if APOs impact the ovarian aging trajectory and subsequent cardiometabolic and musculoskeletal health outcomes.
Our central hypothesis is that APOs will accelerate ovarian aging, resulting in greater incidence and earlier onset of cardiometabolic disease and musculoskeletal decline.
This hypothesis will be tested by accomplishing three aims designed to: 1) define the trajectory of ovarian aging and the impact of APOs on indicators of ovarian aging over time; 2) correlate the ovarian aging trajectory with the development of cardiometabolic risk; and 3) determine the association of ovarian aging biomarker trajectory on musculoskeletal health.
To accomplish these aims we will capitalize on a subset of participants from the large, multisite nuMoM2b cohort that has been followed for fifteen years since the time of their first pregnancy.
This project, the Bone and hEArt health Consequences of Ovarian agiNg (BEACON) Study, will utilize the extensive health, behavior, psychosocial and pregnancy data in this cohort, paired with biospecimens from their initial pregnancy and follow-up visits (3-7 & 7-12 years after pregnancy), as well as data and specimens collected on participants completing an additional study visit.
This proposal has the unique opportunity to provide longitudinal insight into the role of APOs in ovarian aging.
If APOs are shown to accelerate ovarian aging, this mechanism may contribute to earlier onset of vascular dysfunction, metabolic disease, and musculoskeletal decline that would highlight the need for revised risk stratification for women with APOs, earlier screening (e.g., bone density, blood pressure & lipids), and the development of targeted prevention strategies.
Moreover, these findings could identify critical windows for intervention and reveal novel targets for earlier and more effective therapeutic strategies.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Observationel
Tilmelding (Anslået)
655
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: David Haas, MD
- Telefonnummer: 13172742027
- E-mail: dahaas@iu.edu
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Indiana University nuMoM2b-Heart Health Study participants.
Beskrivelse
Inclusion Criteria:
- We will include all IU study participants (n=655) for these analyses to characterize the ovarian aging trajectory of the cohort over time. The approach will allow us to move forward with the ovarian aging biomarker assays while recruitment for the in-person visit is ongoing. We will recruit a subgroup of current the IU cohort (n=352) to complete an in-person study visit at the FIT Core and Clinical Research Center. We will only recruit those who are at least 35 years old to this subgroup.
Exclusion Criteria:
- We will exclude any potential participants who are unable to provide written informed consent in English or Spanish (the only languages allowed at the IU site for nuMoM2b), if the participant is currently pregnant, has undergone recent major surgery or sustained major injury or broken bones within 6 months of recruitment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ovarian aging
Tidsramme: 18 years
|
AMH trajectory
|
18 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. april 2027
Primær færdiggørelse (Anslået)
30. marts 2032
Studieafslutning (Anslået)
30. marts 2032
Datoer for studieregistrering
Først indsendt
27. maj 2026
Først indsendt, der opfyldte QC-kriterier
27. maj 2026
Først opslået (Faktiske)
2. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 31956
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Through HHS-approved methods like DASH or BioData Catalyst
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .