NCT04838678

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1 hypertension

Timeline
4mo left

Started Jul 2021

Longer than P75 for early_phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Jul 2021Aug 2026

First Submitted

Initial submission to the registry

April 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

5.1 years

First QC Date

April 6, 2021

Last Update Submit

August 18, 2025

Conditions

Keywords

NPY

Outcome Measures

Primary Outcomes (2)

  • Blood flow measured by doppler ultrasound

    brachial and femoral artery blood flow

    Acutely on the day of study

  • Muscle sympathetic nervous system activity

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

    Acutely on the day of study

Study Arms (4)

Healthy Control

EXPERIMENTAL

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

Drug: Neuropeptide Y

Hypertensive

EXPERIMENTAL

Hypertensive adults who are not obese

Drug: Neuropeptide Y

Obese

EXPERIMENTAL

Obese adults who are not hypertensive

Drug: Neuropeptide Y

Obese-hypertensive

EXPERIMENTAL

Obese adults who are being treated for hypertension

Drug: Neuropeptide Y

Interventions

intra-arterial infusion of neuropeptide Y

Healthy ControlHypertensiveObeseObese-hypertensive

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

HypertensionObesity

Interventions

Neuropeptide Y

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Central Study Contacts

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Instructor

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 9, 2021

Study Start

July 18, 2021

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations