Influence of Early Menopause on Sympathetic Activation and Cardiovascular Function in Older Women

NCT03692572 | Completed

• 1 other identifier: STU 032018-052
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Women who enter menopause early are at a greater risk for developing cardiovascular disease later in life as compared to women with normal onset of menopause. This increased risk may be due to a prolonged length of time with decreased hormone levels post-menopause; however, this health risk remains understudied. The current study plan to study why women with early menopause are at higher risk for cardiovascular disease by evaluating their sympathetic nervous system and heart-blood vessel function. In addition, there is lack of promising treatment plans for cardiovascular disease in post-menopausal women. Therefore, the current study will also test the impact of dietary nitrate on post-menopausal women to determine if it might serve as a potential treatment to reduce risk of cardiovascular disease in older women.

Conditions

Early Menopause; Menopause

Keywords

Neural control; Cardiovascular function; Inorganic nitrate supplementation

Outcome Measures

Primary Outcomes (1)

• Muscle sympathetic nerve activity (MSNA)

  Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.

  Change from baseline resting MSNA to 2 weeks post nitrate supplementation resting MSNA

Secondary Outcomes (3)

• Cardiac Echocardiogram

  Change from baseline cardiac function to 2 weeks post nitrate supplementation resting cardiac function

• Vascular endothelial function

  Change from baseline brachial artery endothelial function to 2 weeks post nitrate supplementation brachial artery endothelial function

• Arterial stiffness/wave properties

  Change from baseline pulse wave velocity and wave reflection to 2 weeks post nitrate supplementation resting pulse wave velocity and wave reflection

Study Arms (2)

Nitrate supplementation

ACTIVE COMPARATOR

Nitrate rich (6.8 mmol) beet root juice (70ml) twice a day

Dietary Supplement: Nitrate supplementation

Placebo

PLACEBO COMPARATOR

Nitrate depleted (0.04 mmol) placebo juice (70ml) twice a day

Dietary Supplement: placebo

Interventions

Nitrate supplementation DIETARY_SUPPLEMENT

Subjects will drink 70 ml of beet root juice twice a day for 2 weeks.

Nitrate supplementation

placebo DIETARY_SUPPLEMENT

Subjects will drink 70 ml of nitrate depleted placebo juice twice a day for 2 weeks.

Placebo

Eligibility Criteria

• Age: 60 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy normotensive postmenopausal women
• Current age between 60 and 70 years
• Who have experienced "natural" or non-surgical menopause

You may not qualify if:

• Any evidence of cardiopulmonary disease
• History of hormone replacement therapy in the last 5 years
• Chronic kidney disease
• Diabetes mellitus
• Hypertension
• Current abuse of alcohol or drugs and use of tobacco products
• Surgical procedure induced menopause

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Health Resource: collaborator

Study Sites (1)

Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Qi Fu, Ph.D.

  Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only research nurse will have an access to the randomization sheet.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2 groups of women (early and normal menopause transition) will be enrolled to crossover design study in a fashion of randomized and double-blinded.

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 2, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

US (1)