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HypertensionNCT05590546

Sympathetic Transduction in Obesity

An observational study of Hypertension, run by University of Kansas Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Seth Holwerda contact

9729223230

sholwerda@kumc.edu

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 groups in NCT05590546
Study groupRoleWhat they receive
ObeseNo intervention, only performing cross-sectional analysis of pooled data collected in previous studies
Receives: Other: No intervention
ControlNo 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.

  1. 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.

  1. First posted21 Oct 2022
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion19 Nov 2026 (estimated)
  4. Study completion19 Dec 2026 (estimated)

Resources

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)
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

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.

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Sympathetic Transduction in Obesity (NCT05590546) | AzTrials