Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN)

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04838678
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
49.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Neuropeptide Y
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Sympathetic Neural Patterns and Transduction in Obesity-associated Hypertension
Actual Study Start Date :
Jul 18, 2021
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Healthy Control

Healthy age matched controls with no history of cardiovascular disease and normal bodyweight

Drug: Neuropeptide Y
intra-arterial infusion of neuropeptide Y

Experimental: Hypertensive

Hypertensive adults who are not obese

Drug: Neuropeptide Y
intra-arterial infusion of neuropeptide Y

Experimental: Obese

Obese adults who are not hypertensive

Drug: Neuropeptide Y
intra-arterial infusion of neuropeptide Y

Experimental: Obese-hypertensive

Obese adults who are being treated for hypertension

Drug: Neuropeptide Y
intra-arterial infusion of neuropeptide Y

Outcome Measures

Primary Outcome Measures

  1. Blood flow measured by doppler ultrasound [Acutely on the day of study]

    brachial and femoral artery blood flow

  2. Muscle sympathetic nervous system activity [Acutely on the day of study]

    recording of sympathetic nervous system activity from the peroneal or radial nerve

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Control - BMI<30, age 30-55

  • Hypertensive - BMI<30, age 30-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring Obese- BMI>30, age 18-70 Obese-hypertensive- BMI>30, age 30-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring

Exclusion Criteria:

All groups - presence of other significant cardiovascular disease, renal disease, history of smoking, diabetes,

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Texas Southwestern Medical CenterDallasTexasUnited States75231

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Hearon, Assistant Instructor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT04838678
Other Study ID Numbers:
  • STU2020-0749
First Posted:
Apr 9, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christopher Hearon, Assistant Instructor, University of Texas Southwestern Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021