Early MenopauseNCT03692572
Influence of Early Menopause on Sympathetic Activation and Cardiovascular Function in Older Women
A study testing Nitrate supplementation in people with Early Menopause and Menopause, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Menopause, Menopause
- What is being tested?
- Nitrate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy normotensive postmenopausal women
- Current age between 60 and 70 years
- Who have experienced "natural" or non-surgical menopause
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
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.
Read the 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.
- Conditions
- Early Menopause, Menopause
- Being tested
- Nitrate supplementation, placebo
- Keywords
- Neural control, Cardiovascular function, Inorganic nitrate supplementation
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate supplementationDietary supplement
Subjects will drink 70 ml of beet root juice twice a day for 2 weeks.
placeboDietary supplement
Subjects will drink 70 ml of nitrate depleted placebo juice twice a day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nitrate supplementation | Active comparator | Nitrate rich (6.8 mmol) beet root juice (70ml) twice a day Receives: Dietary Supplement: Nitrate supplementation |
| Placebo | Placebo comparator | Nitrate depleted (0.04 mmol) placebo juice (70ml) twice a day Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle sympathetic nerve activity (MSNA)
Muscle sympathetic nerve activity will be measured using microneurography at the peroneal nerve.
Measured: Change from baseline resting MSNA to 2 weeks post nitrate supplementation resting MSNA
Secondary outcomes (3)
Cardiac Echocardiogram
Systolic and diastolic cardiac function will be measured using high resolution ultrasound echocardiogram
Measured: Change from baseline cardiac function to 2 weeks post nitrate supplementation resting cardiac function
Vascular endothelial function
Brachial artery endothelial function will be measured using flow-mediated dilation
Measured: Change from baseline brachial artery endothelial function to 2 weeks post nitrate supplementation brachial artery endothelial function
Arterial stiffness/wave properties
Central and peripheral pulse wave velocity and wave reflection will be assessed using arterial tonometry
Measured: Change from baseline pulse wave velocity and wave reflection to 2 weeks post nitrate supplementation resting pulse wave velocity and wave reflection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MenopauseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Health Resources
- Responsible party
- Principal investigator, Qi Fu, University of Texas Southwestern Medical Center
- Investigators
- Qi Fu, Ph.D., Study director, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692572
- Sponsor's protocol ID
- STU 032018-052
- Status last verified
- Jun 2024
- First submitted
- 25 Sep 2018
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Early Menopause on Sympathetic Activation and Cardiovascular Function in Older Women
- ClinicalTrials.gov ID
- NCT03692572
- Acronym / sponsor ID
- STU 032018-052
- Conditions
- Early Menopause, Menopause
- Keywords
- Neural control, Cardiovascular function, Inorganic nitrate supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Texas Health Resources
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nitrate supplementation | Active comparator | Dietary Supplement: Nitrate supplementationNitrate rich (6.8 mmol) beet root juice (70ml) twice a day |
| Placebo | Placebo comparator | Dietary Supplement: placeboNitrate depleted (0.04 mmol) placebo juice (70ml) twice a day |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy normotensive postmenopausal women
- Current age between 60 and 70 years
- Who have experienced "natural" or non-surgical menopause
Key exclusion criteria (7 listed)
- Any evidence of cardiopulmonary disease
- History of hormone replacement therapy in the last 5 years
- Chronic kidney disease
- Diabetes mellitus
- Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate supplementationSubjects will drink 70 ml of beet root juice twice a day for 2 weeks. | Dietary supplement | Nitrate supplementation |
| placeboSubjects will drink 70 ml of nitrate depleted placebo juice twice a day for 2 weeks. | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
Cardiac Echocardiogram
Time frame: Change from baseline cardiac function to 2 weeks post nitrate supplementation resting cardiac function
Vascular endothelial function
Time frame: Change from baseline brachial artery endothelial function to 2 weeks post nitrate supplementation brachial artery endothelial function
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Fu, Ph.D. study director
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate supplementation in people with Early Menopause and Menopause, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle sympathetic nerve activity (MSNA) (time frame: Change from baseline resting MSNA to 2 weeks post nitrate supplementation resting MSNA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.