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

University of Missouri (MU)

Status and phase: Enrolling; Early Phase 1

Conditions: Aging; Menopause; Vasodilation; Hypoxia

Treatments: Drug: Placebo; Drug: Gemtesa; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT06417177

2100208

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Hypoxia

Experimental group

Description:

Participants will be exposed to hypoxia (low oxygen air) using a mask.

Treatment:

Drug: Propranolol

Drug: Gemtesa

Drug: Placebo

Cold pressor test

Experimental group

Description:

Participants will be exposed to the cold pressor test (ice water on the foot).

Treatment:

Drug: Propranolol

Drug: Gemtesa

Drug: Placebo

Hypercapnia

Experimental group

Description:

Participants will be exposed to hypercapnia (high carbon dioxide air) using a mask.

Treatment:

Drug: Propranolol

Drug: Gemtesa

Drug: Placebo