HypertensionEarly Phase 1OB-HTNNCT04838678
Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN)
A Early Phase 1 study testing Neuropeptide Y in people with Hypertension and Obesity, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand how the nervous system communicates to blood vessels to increase blood pressure during stress. The study will also investigate how hypertension and obesity influence the nervous system and vascular function. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- Neuropeptide Y
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2021to 31 Dec 2026
- Phase
- Early Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Control - BMI<30, age 18-55
- Hypertensive - BMI<30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring Obese- BMI>30, age 18-55 Obese-hypertensive- BMI>30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring
Who cannot join
- All groups - presence of other significant cardiovascular disease, renal disease, history of smoking, diabetes,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75231
CHristopher Hearon, 8155405612, christopherhearon@texashealth.org
About this study
Official title: Sympathetic Neural Patterns and Transduction in Obesity-associated Hypertension
The purpose of this study is to understand how the nervous system communicates to blood vessels to increase blood pressure during stress. The study will also investigate how hypertension and obesity influence the nervous system and vascular function. The study will involve measuring sympathetic nervous system activity and blood flow during common laboratory physiological stress protocols (e.g. hypoxia, exercise), and in response to infusion of drugs that cause vasodilation or vasoconstriction.
- Conditions
- Hypertension, Obesity
- Being tested
- Neuropeptide Y
- Keywords
- NPY
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropeptide YDrug
intra-arterial infusion of neuropeptide Y
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Experimental | Healthy age matched controls with no history of cardiovascular disease and normal bodyweight Receives: Drug: Neuropeptide Y |
| Hypertensive | Experimental | Hypertensive adults who are not obese Receives: Drug: Neuropeptide Y |
| Obese | Experimental | Obese adults who are not hypertensive Receives: Drug: Neuropeptide Y |
| Obese-hypertensive | Experimental | Obese adults who are being treated for hypertension Receives: Drug: Neuropeptide Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow measured by doppler ultrasound
brachial and femoral artery blood flow
Measured: Acutely on the day of study
Muscle sympathetic nervous system activity
recording of sympathetic nervous system activity from the peroneal or radial nerve
Measured: Acutely on the day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start18 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 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.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hearon, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838678
- Sponsor's protocol ID
- STU2020-0749
- Acronym
- OB-HTN
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2021
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Neural Patterns and Transduction in Obesity-associated Hypertension
- ClinicalTrials.gov ID
- NCT04838678
- Acronym / sponsor ID
- OB-HTN / STU2020-0749
- Conditions
- Hypertension, Obesity
- Keywords
- NPY
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2021 (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.
The purpose of this study is to understand how the nervous system communicates to blood vessels to increase blood pressure during stress. The study will also investigate how hypertension and obesity influence the nervous system and vascular function. The study will involve measuring sympathetic nervous system activity and blood flow during common laboratory physiological stress protocols (e.g. hypoxia, exercise), and in response to infusion of drugs that cause vasodilation or vasoconstriction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Experimental | Drug: Neuropeptide YHealthy age matched controls with no history of cardiovascular disease and normal bodyweight |
| Hypertensive | Experimental | Drug: Neuropeptide YHypertensive adults who are not obese |
| Obese | Experimental | Drug: Neuropeptide YObese adults who are not hypertensive |
| Obese-hypertensive | Experimental | Drug: Neuropeptide YObese adults who are being treated for hypertension |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Control - BMI<30, age 18-55
- Hypertensive - BMI<30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring Obese- BMI>30, age 18-55 Obese-hypertensive- BMI>30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring
Key exclusion criteria (1 listed)
- All groups - presence of other significant cardiovascular disease, renal disease, history of smoking, diabetes,
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 |
|---|---|---|
| Neuropeptide Yintra-arterial infusion of neuropeptide Y | Drug | Healthy Control, Hypertensive, Obese, Obese-hypertensive |
Primary outcome
Blood flow measured by doppler ultrasound
Time frame: Acutely on the day of study
brachial and femoral artery blood flow
Muscle sympathetic nervous system activity
Time frame: Acutely on the day of study
recording of sympathetic nervous system activity from the peroneal or radial nerve
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 Sep 2026.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neuropeptide Y in people with Hypertension and Obesity, 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christopher M Hearon, Ph.D. (214-345-4624, christopher.hearon@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow measured by doppler ultrasound (time frame: Acutely on the day of study). The study lists 2 primary outcomes in all. 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 Sep 2026.