Rol van de menopauze bij thermoregulatie
De invloed van oestrogeen op de thermoregulerende reacties op hittestress bij pre- en postmenopauzale vrouwen
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: W. Larry Kenney, Ph.D.
- Telefoonnummer: 814-863-1672
- E-mail: w7k@psu.edu
Studie Contact Back-up
- Naam: Olivia K. Leach, MS
- E-mail: okl5046@psu.edu
Studie Locaties
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Pennsylvania
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University Park, Pennsylvania, Verenigde Staten, 16802
- Werving
- Noll Laboratory
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Contact:
- W. Larry Kenney, Ph.D.
- Telefoonnummer: 814-863-1672
- E-mail: w7k@psu.edu
-
Contact:
- Olivia Leach, MS
- E-mail: okl5046@psu.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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
Andere namen:
placebo tablet |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Skin Blood Flow
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Body Mass
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: W. Larry Kenney, Ph.D., The Pennsylvania State University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Study 25435
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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