Rollen til overgangsalderen i termoregulering
Estrogenens innflytelse på de termoregulerende responsene på varmestress hos kvinner før og postmenopausale kvinner
The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men.
Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Premenopausal and postmenopausal women will be recruited and different interventions will be given to each group. To mimic a postmenopausal hormone profile, premenopausal women will be given a GnRH antagonist, which acutely reduces estrogen concentrations. This induces a temporary post-menopausal state without compounding aging effects. Postmenopausal women will be given a transdermal estradiol patch to acutely raise estrogen concentrations. Supplementing estrogen in postmenopausal women allows for the effect of menopausal low estrogen concentration to be removed from the physiological effects of aging.
Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles.
Each subject will complete 6 (3 for each treatment) experimental trials. For each intervention, participants will complete one passive heating experiment first, followed by two active heating experiments.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: W. Larry Kenney, Ph.D.
- Telefonnummer: 814-863-1672
- E-post: w7k@psu.edu
Studer Kontakt Backup
- Navn: Olivia K. Leach, MS
- E-post: okl5046@psu.edu
Studiesteder
-
-
Pennsylvania
-
University Park, Pennsylvania, Forente stater, 16802
- Rekruttering
- Noll Laboratory
-
Ta kontakt med:
- W. Larry Kenney, Ph.D.
- Telefonnummer: 814-863-1672
- E-post: w7k@psu.edu
-
Ta kontakt med:
- Olivia Leach, MS
- E-post: okl5046@psu.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Women ages 42-64
Exclusion Criteria:
- Chron's disease, diverticulitis, or similar gastrointestinal disease
- Abnormal resting exercise electrocardiogram (ECG)
- Tobacco use
- High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor
- Assessment
- Using hormone therapy
- Using hormonal contraceptives
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Premenopausal estrogen suppression
Participants take a cellulose placebo tablet for 4 days prior to baseline testing and continue until experimental visits are complete. Following completion of placebo testing, participants begin taking 400 mg/day Elagolix for 4 days prior to testing and continue until experimental visits are complete. |
2 x 200 mg tablet
Andre navn:
placebo tablet |
|
Eksperimentell: Postmenopausal estrogen supplementation
Participants wear a transdermal estradiol patch or placebo patch for 5 days prior to testing and continue until experimental visits are complete. After 48 hr washout, participants then wear the alternative treatment for 5 days prior to testing until experimental visits are complete. |
0.05 mg/day patch placebo patch |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skin Blood Flow
Tidsramme: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
Skin blood flow response to whole body heating is continuously monitored |
Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
|
Local Sweat Rate
Tidsramme: Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
A small sweat capsule is placed on the forearm for the duration of whole body heating. |
Monitored continuously during both 3 hour passive heating experiments (Visit 1 and Visit 3 approx 3 weeks)
|
|
Core Temperature
Tidsramme: Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)
|
Changes in body temperature are measured through a telemetry pill swallowed before each experiment. |
Monitored continuously during all 3 hour experimental visits (6 total average of 3 weeks)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Mass
Tidsramme: Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
Body mass is measured on a scale. |
Baseline and following 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
|
Skin Temperature
Tidsramme: Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
Mean skin temperature is calculated from a weighted average of skin temperature from 4 different sites. |
Calculated continuously for the duration of each 3 hr experimental visit (6 total visits for study completion, an average of 3 weeks)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: W. Larry Kenney, Ph.D., The Pennsylvania State University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Study 25435
Legemiddel- og utstyrsinformasjon, studiedokumenter
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