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The Cardiovascular Impact of Hot Flushes
The overall objective of this study is to examine the physiological responses that occur during a hot flush in postmenopausal women. The following specific aims will be executed to reach the overall objective of this study. Aim 1: To determine if hot flushes can be reliably induced with a temperature-controlled, water- circulating (TCWC) heating pad. Based on previous research, the investigators hypothesize that hot flushes will be inducible with the TCWC in symptomatic women, but not in asymptomatic women. Aim 2: To determine if heat-induced hot flushes in symptomatic women will cause reproducible cardiovascular and respiratory responses. The investigators hypothesize that heat-induced hot flushes produce similar and reproducible cardiovascular and respiratory responses to spontaneous hot flushes. Aim 3: To determine if body fat percentage influences hot flush severity or frequency during spontaneous or induced hot flushes. The investigators hypothesize that women with higher body fat have reduced hot flash severity and frequency.
Conditions:
🦠 Hot Flashes 🦠 Menopause
🗓️ Study Start (Actual) 1 March 2022
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Postmenopausal (may have or may not have hot flushes)
    • * Have not started hormone therapy and/or will discontinue hormone therapy for the duration of the study

    Exclusion Criteria:

    • * Reported nicotine/tobacco use within the last six months
    • * Diabetic or asthmatic
    • * Diagnosed significant carotid stenosis
    • * History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
    • * Existing metabolic or endocrine abnormalities
    • * Use of heart/blood pressure medications that are determined to interfere with study outcomes
    • * Unwilling to discontinue use of OC (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or MHT
    • * Pregnant or breastfeeding
    • * Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two or three
    • * Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
    • * Unwilling or unable to fast in the eight hours before visit two or three
    • * Body mass index greater than or equal to 35 kg/m\^3
Ages Eligible for Study: 40 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 January 2022
  • First Submitted that Met QC Criteria 10 February 2022
  • First Posted 22 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 July 2024
  • Last Update Posted 9 July 2024
  • Last Verified July 2024
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