## Protocol Section
### Identification Module
**NCT ID:** NCT06417177

**Brief Title:** Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

**Official Title:** Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia

#### Organization Study ID Info
**ID:** 2100208
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Missouri-Columbia

#### Responsible Party

**Investigator Affiliation:** University of Missouri-Columbia

**Investigator Full Name:** Jacqueline K Limberg, PhD

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Aging

- Menopause

- Hypoxia

- Vasodilation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 75

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will be exposed to low oxygen air using a mask.

**Intervention Names:**

- Drug: Placebo

- Drug: Propranolol

- Drug: Gemtesa

**Label:** Hypoxia

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will be exposed to ice water on the foot.

**Intervention Names:**

- Drug: Placebo

- Drug: Propranolol

- Drug: Gemtesa

**Label:** Cold pressor test

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will be exposed to high carbon dioxide air using a mask.

**Intervention Names:**

- Drug: Placebo

- Drug: Propranolol

- Drug: Gemtesa

**Label:** Hypercapnia

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cold pressor test

- Hypercapnia

- Hypoxia

**Description:** Participants will receive a placebo in pill form.

**Name:** Placebo

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Cold pressor test

- Hypercapnia

- Hypoxia

**Description:** Participants will receive oral propranolol (1 mg/kg).

**Name:** Propranolol

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Cold pressor test

- Hypercapnia

- Hypoxia

**Description:** Participants will receive oral gemtesa (75 mg).

**Name:** Gemtesa

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Blood flow in the forearm measured with venous occlusion plethysmography.

**Measure:** Forearm blood flow

**Time Frame:** Change from baseline to 5 minutes.

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** limberglab@missouri.edu

**Name:** Jacqueline Limberg

**Phone:** 573-882-2544

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4185

- Name: Hypoxia

- Relevance: HIGH

- As Found: Hypoxia

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: T6036

- Name: Menopause

- Relevance: HIGH

- As Found: Menopause

### Condition Browse Module - Meshes

- ID: D000000860

- Term: Hypoxia

### Intervention Browse Module - Ancestors

- ID: D000000319

- Term: Adrenergic beta-Antagonists

- ID: D000018674

- Term: Adrenergic Antagonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000000959

- Term: Antihypertensive Agents

- ID: D000014665

- Term: Vasodilator Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M14298

- Name: Propranolol

- Relevance: HIGH

- As Found: ER

- ID: M3671

- Name: Adrenergic beta-Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20755

- Name: Adrenergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17412

- Name: Vasodilator Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000011433

- Term: Propranolol

### Misc Info Module

- Version Holder: 2024-05-31
