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Neuropeptide Y for High Blood Pressure (OB-HTN Trial)

Phase < 1
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Control - BMI<30, age 18-55
Hypertensive - BMI<30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring
Must not have
All groups - presence of other significant cardiovascular disease
All groups - renal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up acutely on the day of study
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers understand how the nervous system communicates with blood vessels to increase blood pressure during stress, and how hypertension and obesity may influence this process.

Who is the study for?
This trial is for adults aged 18-55 who are either healthy, overweight (BMI>30), have high blood pressure, or both. Participants must not have other significant cardiovascular diseases, kidney disease, a history of smoking, or diabetes.
What is being tested?
The study aims to understand how stress affects blood pressure in people with obesity and/or hypertension by measuring nervous system activity and blood flow during stress tests and drug-induced changes in vessel size.
What are the potential side effects?
Potential side effects may include reactions to the infusion such as discomfort at the injection site or allergic reactions. Stress tests might cause temporary increases in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old with a BMI under 30.
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I am 18-55 years old, have a BMI under 30, and my high blood pressure was confirmed by a 24-hour monitor.
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I am between 18 and 55 years old with a BMI over 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a significant heart condition.
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I have kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~acutely on the day of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and acutely on the day of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood flow measured by doppler ultrasound
Muscle sympathetic nervous system activity

Side effects data

From 2017 Phase 4 trial • 18 Patients • NCT02639637
8%
paresthesias
8%
Light-headedness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitagliptin (Diabetics and Controls)
Placebo (Diabetics and Controls)
Placebo and Valsartan (Controls Only)
Sitagliptin and Valsartan (Controls Only)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Obese-hypertensiveExperimental Treatment1 Intervention
Obese adults who are being treated for hypertension
Group II: ObeseExperimental Treatment1 Intervention
Obese adults who are not hypertensive
Group III: HypertensiveExperimental Treatment1 Intervention
Hypertensive adults who are not obese
Group IV: Healthy ControlExperimental Treatment1 Intervention
Healthy age matched controls with no history of cardiovascular disease and normal bodyweight
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuropeptide Y
2012
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,080 Previous Clinical Trials
1,056,189 Total Patients Enrolled

Media Library

Neuropeptide Y Clinical Trial Eligibility Overview. Trial Name: NCT04838678 — Phase < 1
High Blood Pressure Research Study Groups: Hypertensive, Obese, Obese-hypertensive, Healthy Control
High Blood Pressure Clinical Trial 2023: Neuropeptide Y Highlights & Side Effects. Trial Name: NCT04838678 — Phase < 1
Neuropeptide Y 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838678 — Phase < 1
~18 spots leftby Sep 2025
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