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

Primary Purpose

Hypertension, Obesity

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Neuropeptide Y

About this trial

This is an interventional basic science trial for Hypertension focused on measuring NPY

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Healthy Control

Hypertensive

Obese

Obese-hypertensive

Arm Description

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

Hypertensive adults who are not obese

Obese adults who are not hypertensive

Obese adults who are being treated for hypertension

Outcomes

Primary Outcome Measures

Blood flow measured by doppler ultrasound

brachial and femoral artery blood flow

Muscle sympathetic nervous system activity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04838678

First Posted

April 6, 2021

Last Updated

August 21, 2023

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04838678

Brief Title

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

Acronym

OB-HTN

Official Title

Sympathetic Neural Patterns and Transduction in Obesity-associated Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 18, 2021 (Actual)

Primary Completion Date

September 2025 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Obesity

Keywords

NPY

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Control

Arm Type

Experimental

Arm Description

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

Arm Title

Hypertensive

Arm Type

Experimental

Arm Description

Hypertensive adults who are not obese

Arm Title

Obese

Arm Type

Experimental

Arm Description

Obese adults who are not hypertensive

Arm Title

Obese-hypertensive

Arm Type

Experimental

Arm Description

Obese adults who are being treated for hypertension

Intervention Type

Drug

Intervention Name(s)

Neuropeptide Y

Intervention Description

intra-arterial infusion of neuropeptide Y

Primary Outcome Measure Information:

Title

Blood flow measured by doppler ultrasound

Description

brachial and femoral artery blood flow

Time Frame

Acutely on the day of study

Title

Muscle sympathetic nervous system activity

Description

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

Time Frame

Acutely on the day of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: All groups - presence of other significant cardiovascular disease, renal disease, history of smoking, diabetes,

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christopher M Hearon, Ph.D.

Phone

214-345-4624

christopher.hearon@utsouthwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Childers

Phone

214-345-6459

marychilders@texashealth.org

Facility Information:

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

CHristopher Hearon

Phone

815-540-5612

christopherhearon@texashealth.org

12. IPD Sharing Statement

Learn more about this trial

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

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