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)
• Enrollment: 100
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 49.5
• Patients Per Site Per Month: 2

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 Disease	Intervention/Treatment	Phase
Hypertension; Obesity	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

Arm	Intervention/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: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75231

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: Aug 10, 2022
• Last Verified: Aug 1, 2022

• 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: NPY
• Additional relevant MeSH terms: Hypertension; Obesity

Study Results

No Results Posted as of Aug 10, 2022