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

Early Phase 1

Recruiting

• Conditions: Hypoxia; Aging; Menopause; Vasodilation
• Interventions: Drug: Placebo; Drug: Propranolol; Drug: Gemtesa

• Registration Number: NCT06417177
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-16
• Study Start: 2024-06-03
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cold pressor test	Gemtesa	Participants will be exposed to the cold pressor test (ice water on the foot).
Hypoxia	Placebo	Participants will be exposed to hypoxia (low oxygen air) using a mask.
Hypoxia	Gemtesa	Participants will be exposed to hypoxia (low oxygen air) using a mask.
Cold pressor test	Placebo	Participants will be exposed to the cold pressor test (ice water on the foot).
Hypercapnia	Placebo	Participants will be exposed to hypercapnia (high carbon dioxide air) using a mask.
Cold pressor test	Propranolol	Participants will be exposed to the cold pressor test (ice water on the foot).
Hypoxia	Propranolol	Participants will be exposed to hypoxia (low oxygen air) using a mask.
Hypercapnia	Propranolol	Participants will be exposed to hypercapnia (high carbon dioxide air) using a mask.
Hypercapnia	Gemtesa	Participants will be exposed to hypercapnia (high carbon dioxide air) using a mask.

Primary Outcome Measures

Name	Time	Method
Forearm blood flow	Change from baseline to 5 minutes.	Blood flow in the forearm measured with venous occlusion plethysmography.

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States