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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03692572
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Texas Health Resource
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Early Menopause Menopause Dietary Supplement: Nitrate supplementation Dietary Supplement: placebo Not Applicable

Detailed Description:

The current study is recruiting two groups of women aged between 60-70 years old; 1) women who had early natural/non-surgical menopause (age 40-44 yrs) and 2) women who had normal natural/non-surgical menopause (age 50-54). The investigators are recruiting women who do not have any cardiovascular disease, hypertension, diabetes, and other major health issue.

The main hypothesis of the project is that early menopause negatively impacts the heart, blood vessel and nerve system due to the increased length of time with reduced hormone levels; which could explain the relationship between early menopause and greater risk of cardiovascular disease in later life. Sympathetic nerve system and cardiovascular functions will be evaluated in both groups to compare the impact of prolonged hormone deficiency. In addition, current study will examine the impact of inorganic nitrate supplementation (beet root juice) to see if there are any favorable changes after 2 weeks of beet root juice intake. There are 2 main test visits in the current study.

Visit 1. Nerve system test (maximally take about 5 hours): Participants will rest in the supine position for ≥ 20 mins. Resting heart rate, breathing rate, finger blood pressure will be monitored. Cardiac output will be assessed using the acetylene gas rebreathing technique (1 hour). IV will be inserted for blood draw. Nerve signal search will be performed using a thin needle behind knee to find a signal from a specific nerve. At the same time, transcranial Doppler probe will be placed on the head to look at brain blood flow using soft head gear (1-2 hour). After acceptable signals are obtained, baseline data collection will begin. It will be followed by handgrip exercise and hand immersion to cold water to examine neural sympathetic response to different stimuli (30 mins). After this, to evaluate nerve response to different degrees of passive standings, a bed will be tilted to 30° and 60° for 8 mins each. Blood samples will be obtained in the supine resting position and at the end of 60° tilt (45 mins).

Visit 2. Heart and vessel function assessment (Proximately take 2 hours): All measurements are non-invasive for this visit. Participants will rest in the supine position for ≥ 20 mins. Resting heart function will be assessed by ultrasound echocardiography (30mins). Vascular stiffness measurement will be performed using a probe placed on wrist, neck and leg groin area (30 mins). Vascular endothelial function will be measured using flow-mediated dilation and followed by smooth muscle responsiveness test will be performed by measuring brachial artery diameter changes for 10 min following 0.4 mg sublingual nitroglycerin administration (1 hour).

After Visit 1-2, participant will be asked to drink either dietary nitrate supplementation or placebo for 2 weeks (randomly assigned). After 2 weeks intervention, participant will come back for post-intervention tests which are identical to visit 1 and 2.

After completion of the first intervention, participants will have at least 2 weeks of wash-out period. After 2 weeks participant will be back to the lab and repeat the visit 1 and 2, as well as 2 weeks of dietary nitrate supplementation or placebo. (For those who received 2 weeks of nitrate supplementation for the first intervention, it will be a placebo for this intervention. For those who received placebo for the first intervention, it will be a nitrate supplementation for this intervention). After intervention participants will repeat the visit 1 and 2 again.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2 groups of women (early and normal menopause transition) will be enrolled to crossover design study in a fashion of randomized and double-blinded.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Only research nurse will have an access to the randomization sheet.
Primary Purpose: Prevention
Official Title: Influence of Early Menopause on Sympathetic Activation and Cardiovascular Function in Older Women
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitrate supplementation
Nitrate rich (6.8 mmol) beet root juice (70ml) twice a day
Dietary Supplement: Nitrate supplementation
Subjects will drink 70 ml of beet root juice twice a day for 2 weeks.

Placebo Comparator: Placebo
Nitrate depleted (0.04 mmol) placebo juice (70ml) twice a day
Dietary Supplement: placebo
Subjects will drink 70 ml of nitrate depleted placebo juice twice a day for 2 weeks.




Primary Outcome Measures :
  1. Muscle sympathetic nerve activity (MSNA) [ Time Frame: Change from baseline resting MSNA to 2 weeks post nitrate supplementation resting MSNA ]
    Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.


Secondary Outcome Measures :
  1. Cardiac Echocardiogram [ Time Frame: Change from baseline cardiac function to 2 weeks post nitrate supplementation resting cardiac function ]
    Systolic and diastolic cardiac function will be measured using high resolution ultrasound echocardiogram

  2. Vascular endothelial function [ Time Frame: Change from baseline brachial artery endothelial function to 2 weeks post nitrate supplementation brachial artery endothelial function ]
    Brachial artery endothelial function will be measured using flow-mediated dilation

  3. Arterial stiffness/wave properties [ Time Frame: Change from baseline pulse wave velocity and wave reflection to 2 weeks post nitrate supplementation resting pulse wave velocity and wave reflection ]
    Central and peripheral pulse wave velocity and wave reflection will be assessed using arterial tonometry



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692572


Contacts
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Contact: Jeungki Yoo, Ph.D. 214-345-4184 JeungkiYoo@Texashealth.org
Contact: Monique Roberts, RN 214-345-4656 MoniqueRoberts-Reeves@texashealth.org

Locations
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United States, Texas
Institute for Exercise and Environmental Medicine Recruiting
Dallas, Texas, United States, 75231
Contact: Rosemary Parker    214-345-4607    IEEMPregnancy@Texashealth.org   
Contact: Mary Childers    214-345-6459    MaryChilders@Texashealth.org   
Principal Investigator: Jeungki Yoo, Ph.D         
Principal Investigator: Qi Fu, Ph.D         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Texas Health Resource
Investigators
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Study Director: Qi Fu, Ph.D. Faculty

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03692572    
Other Study ID Numbers: STU 032018-052
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
Neural control
Cardiovascular function
Inorganic nitrate supplementation
Additional relevant MeSH terms:
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Menopause, Premature
Primary Ovarian Insufficiency
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases