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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04838678
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Christopher Hearon, University of Texas Southwestern Medical Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 18, 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Blood flow measured by doppler ultrasound [ Time Frame: Acutely on the day of study ]
    brachial and femoral artery blood flow

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838678


Contacts
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Contact: Christopher M Hearon, Ph.D. 214-345-4624 christopher.hearon@utsouthwestern.edu
Contact: Mary Childers 214-345-6459 marychilders@texashealth.org

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75231
Contact: CHristopher Hearon    815-540-5612    christopherhearon@texashealth.org   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
More Information
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Responsible Party: Christopher Hearon, Assistant Instructor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04838678    
Other Study ID Numbers: STU2020-0749
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Hearon, University of Texas Southwestern Medical Center:
NPY
Additional relevant MeSH terms:
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Hypertension
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Vascular Diseases
Cardiovascular Diseases