HypertensionNCT05590546
Sympathetic Transduction in Obesity
An observational study of Hypertension, run by University of Kansas Medical Center.
Trial summary
Central (abdominal) obesity is associated with elevated adrenergic activity and arterial blood pressure (BP). Therefore, we tested the hypothesis that transduction of spontaneous muscle sympathetic nerve activity (MSNA) to BP, i.e., sympathetic transduction, is augmented in abdominal obesity (increased waist… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 19 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Otherwise healthy
Who may be able to join
- Nonsmokers
- free of metabolic or neurological disease
- waist circumference > 102 cm for men and > 88 cm for women or waist circumference was < 94 cm for men and < 80 cm for women.
Who cannot join
- Use of anti-hypertensive medications
- history of diabetes
- history of smoking within 3 months prior to study participation
- hypertension determined by 24-hour ambulatory average BP (<130/80 mmHg).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Concomitantly Higher Resting Arterial Blood Pressure and Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
Central (abdominal) obesity is associated with elevated adrenergic activity and arterial blood pressure (BP). Therefore, we tested the hypothesis that transduction of spontaneous muscle sympathetic nerve activity (MSNA) to BP, i.e., sympathetic transduction, is augmented in abdominal obesity (increased waist circumference) and positively related to prevailing BP.
Read the detailed description
The prevalence of obesity has increased to over 42% of adults in the United States. Obesity, particularly elevations in central adiposity, is associated with the development of hypertension, which is a prominent cause of cardiovascular diseases (CVD), such as stroke, myocardial infarction, heart failure, and chronic kidney disease. Pathophysiology of obesity hypertension includes several different categories of mechanisms, such as sympathetic activation, inflammation, and renal dysfunction. However, the relative importance and contribution of these mechanisms to the initiation of obesity hypertension remains uncertain.
Obesity is characterized by elevated peripheral vascular tone. Specifically, larger decreases in arterial blood pressure (BP) were observed following ganglionic blockade (trimethaphan) in obese individuals compared with non-obese controls, suggesting greater autonomic support of BP in obesity. Similarly, 4 weeks of combined α- and β-adrenergic receptor blockade produced larger reductions in BP in obese participants with hypertension compared with non-obese control with hypertension. These data are consistent with the large body of evidence suggesting that obesity elevates muscle sympathetic nerve activity (MSNA). However, MSNA may not be elevated in obesity if development of hypertension is absent. Therefore, the extent to which MSNA contributes to the initial development of BP dysregulation in obese men and women without hypertension remains unclear.
Obesity-related increases in vascular tone may be, in part, a result of increased vascular responsiveness to MSNA. In fact, elevated vascular responsiveness to MSNA has been reported in obesity-related conditions such as type 2 diabetes. However, only one study has directly examined sympathetic vascular tone in obese subjects without hypertension, reporting similar passive increases in forearm blood flow following α-adrenergic receptor blockade when compared to age- and sex-matched non-obese participants. These data suggest that obesity alone does not alter passive dilation of the forearm resulting from α-adrenergic receptor blockade. However, an extrapolation to systemic BP regulation in obesity from an examination of forearm dilation is challenging for several reasons. First, passive dilation following α-adrenergic receptor blockade may not reflect the blood flow response to α-adrenergic receptor activation, i.e., endogenous sympathetic activation. Second, in normal adults, vascular responsiveness to sympathetic innervation is heterogenous across vascular regions. For example, the lower limbs exhibit greater vascular sensitivity to sympathetic stimulation compared with the forearm vasculature as a result of greater α-adrenergic receptor density and/or sensitivity in the lower limbs. Third, obese individuals exhibit regional differences in endogenous norepinephrine kinetics compared with non-obese individuals. Thus, although regional sympathetic vascular tone has been assessed in obesity, there are limited data available regarding potential alterations in systemic BP responsiveness to endogenous activation of adrenergic receptors in this population who are highly prone to development of hypertension.
Therefore, a technique that quantifies the systemic pressor response to spontaneous bursts of MSNA with high temporal resolution (i.e., sympathetic transduction) is used. It is hypothesized that sympathetic transduction would be augmented in young/middle-aged men and women with abdominal obesity (increased waist circumference) compared with age- and sex-matched non-obese controls. It is further hypothesized that augmented sympathetic transduction in obesity would be positively related to higher prevailing BP.
- Conditions
- Hypertension
- Being tested
- No intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, only performing cross-sectional analysis of pooled data collected in previous studies
| Study group | Role | What they receive |
|---|---|---|
| Obese | No intervention, only performing cross-sectional analysis of pooled data collected in previous studies Receives: Other: No intervention | |
| Control | No intervention, only performing cross-sectional analysis of pooled data collected in previous studies Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic transduction
signal averaging was performed in which bursts of MSNA act as a trigger and beat-to-beat BP was tracked for 15 subsequent cardiac cycles thereafter.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Oct 2025 (estimated)
- Primary completion19 Nov 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Holwerda PhD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590546
- Sponsor's protocol ID
- TRANSDUCTION_IN_OBESITY
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2022
- Last updated
- 3 Oct 2024
- Results posted
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitantly Higher Resting Arterial Blood Pressure and Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
- ClinicalTrials.gov ID
- NCT05590546
- Acronym / sponsor ID
- TRANSDUCTION_IN_OBESITY
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 21 Oct 2022 (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.
Central (abdominal) obesity is associated with elevated adrenergic activity and arterial blood pressure (BP). Therefore, we tested the hypothesis that transduction of spontaneous muscle sympathetic nerve activity (MSNA) to BP, i.e., sympathetic transduction, is augmented in abdominal obesity (increased waist circumference) and positively related to prevailing BP.
Detailed description
The prevalence of obesity has increased to over 42% of adults in the United States. Obesity, particularly elevations in central adiposity, is associated with the development of hypertension, which is a prominent cause of cardiovascular diseases (CVD), such as stroke, myocardial infarction, heart failure, and chronic kidney disease. Pathophysiology of obesity hypertension includes several different categories of mechanisms, such as sympathetic activation, inflammation, and renal dysfunction. However, the relative importance and contribution of these mechanisms to the initiation of obesity hypertension remains uncertain.
Obesity is characterized by elevated peripheral vascular tone. Specifically, larger decreases in arterial blood pressure (BP) were observed following ganglionic blockade (trimethaphan) in obese individuals compared with non-obese controls, suggesting greater autonomic support of BP in obesity. Similarly, 4 weeks of combined α- and β-adrenergic receptor blockade produced larger reductions in BP in obese participants with hypertension compared with non-obese control with hypertension. These data are consistent with the large body of evidence suggesting that obesity elevates muscle sympathetic nerve activity (MSNA). However, MSNA may not be elevated in obesity if development of hypertension is absent. Therefore, the extent to which MSNA contributes to the initial development of BP dysregulation in obese men and women without hypertension remains unclear.
Obesity-related increases in vascular tone may be, in part, a result of increased vascular responsiveness to MSNA. In fact, elevated vascular responsiveness to MSNA has been reported in obesity-related conditions such as type 2 diabetes. However, only one study has directly examined sympathetic vascular tone in obese subjects without hypertension, reporting similar passive increases in forearm blood flow following α-adrenergic receptor blockade when compared to age- and sex-matched non-obese participants. These data suggest that obesity alone does not alter passive dilation of the forearm resulting from α-adrenergic receptor blockade. However, an extrapolation to systemic BP regulation in obesity from an examination of forearm dilation is challenging for several reasons. First, passive dilation following α-adrenergic receptor blockade may not reflect the blood flow response to α-adrenergic receptor activation, i.e., endogenous sympathetic activation. Second, in normal adults, vascular responsiveness to sympathetic innervation is heterogenous across vascular regions. For example, the lower limbs exhibit greater vascular sensitivity to sympathetic stimulation compared with the forearm vasculature as a result of greater α-adrenergic receptor density and/or sensitivity in the lower limbs. Third, obese individuals exhibit regional differences in endogenous norepinephrine kinetics compared with non-obese individuals. Thus, although regional sympathetic vascular tone has been assessed in obesity, there are limited data available regarding potential alterations in systemic BP responsiveness to endogenous activation of adrenergic receptors in this population who are highly prone to development of hypertension.
Therefore, a technique that quantifies the systemic pressor response to spontaneous bursts of MSNA with high temporal resolution (i.e., sympathetic transduction) is used. It is hypothesized that sympathetic transduction would be augmented in young/middle-aged men and women with abdominal obesity (increased waist circumference) compared with age- and sex-matched non-obese controls. It is further hypothesized that augmented sympathetic transduction in obesity would be positively related to higher prevailing BP.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Other: No interventionNo intervention, only performing cross-sectional analysis of pooled data collected in previous studies |
| Control | – | Other: No interventionNo intervention, only performing cross-sectional analysis of pooled data collected in previous studies |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Otherwise healthy
Key inclusion criteria (3 listed)
- Nonsmokers
- free of metabolic or neurological disease
- waist circumference > 102 cm for men and > 88 cm for women or waist circumference was < 94 cm for men and < 80 cm for women.
Key exclusion criteria (4 listed)
- Use of anti-hypertensive medications
- history of diabetes
- history of smoking within 3 months prior to study participation
- hypertension determined by 24-hour ambulatory average BP (<130/80 mmHg).
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 |
|---|---|---|
| No interventionNo intervention, only performing cross-sectional analysis of pooled data collected in previous studies | Other | Control, Obese |
Primary outcome
Sympathetic transduction
Time frame: 15 min
signal averaging was performed in which bursts of MSNA act as a trigger and beat-to-beat BP was tracked for 15 subsequent cardiac cycles thereafter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of Kansas Medical Center.
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 4 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: opening soon, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seth Holwerda (9729223230, sholwerda@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic transduction (time frame: 15 min). 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 3 Oct 2024.