Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia (2100208)

May 15, 2024 updated by: Jacqueline K Limberg, PhD, University of Missouri-Columbia
The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female assigned at birth
  • Pre, peri- or post-menopausal
  • Healthy weight (BMI ≥18 and ≤30 kg/m2)

Exclusion Criteria:

  • Male (assigned at birth)
  • Pregnancy, breastfeeding
  • Use of hormone replacement therapies
  • Hysterectomy
  • Body mass index >30 kg/m2
  • Diagnosed sleep apnea
  • Current smoking/Nicotine/Drug use
  • Nerve/neurologic disease
  • Cardiovascular, hepatic, renal, respiratory disease
  • Blood pressure ≥140/90 mmHg
  • Diabetes, Polycystic ovarian syndrome
  • Communication barriers
  • Prescription medications
  • Malignant cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypoxia
Participants will be exposed to low oxygen air using a mask.
Drug: Placebo
Participants will receive a placebo in pill form.
Drug: Propranolol
Participants will receive oral propranolol (1 mg/kg).
Drug: Gemtesa
Participants will receive oral gemtesa (75 mg).
Experimental: Cold pressor test
Participants will be exposed to ice water on the foot.
Drug: Placebo
Participants will receive a placebo in pill form.
Drug: Propranolol
Participants will receive oral propranolol (1 mg/kg).
Drug: Gemtesa
Participants will receive oral gemtesa (75 mg).
Experimental: Hypercapnia
Participants will be exposed to high carbon dioxide air using a mask.
Drug: Placebo
Participants will receive a placebo in pill form.
Drug: Propranolol
Participants will receive oral propranolol (1 mg/kg).
Drug: Gemtesa
Participants will receive oral gemtesa (75 mg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forearm blood flow
Time Frame: Change from baseline to 5 minutes.
Blood flow in the forearm measured with venous occlusion plethysmography.
Change from baseline to 5 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

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 Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2100208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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