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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 belowSelect...
I am between 18 and 55 years old with a BMI under 30.
Select...
I am 18-55 years old, have a BMI under 30, and my high blood pressure was confirmed by a 24-hour monitor.
Select...
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:Select...
I have a significant heart condition.
Select...
I have kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ acutely on the day of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~acutely on the day of study
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 • NCT026396378%
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
1,088 Previous Clinical Trials
1,059,260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 55 years old with a BMI under 30.People with diabetes are not allowed in the study.If you are between the ages of 18 and 55 and have high blood pressure, you may not be eligible if you are not obese, or if your body mass index (BMI) is less than 30.I am between 18-55, have a BMI over 30, and diagnosed with high blood pressure.I have a significant heart condition.I am 18-55 years old, have a BMI under 30, and my high blood pressure was confirmed by a 24-hour monitor.I have kidney disease.You have a history of smoking.I am between 18 and 55 years old with a BMI over 30.
Research Study Groups:
This trial has the following groups:- Group 1: Hypertensive
- Group 2: Obese
- Group 3: Obese-hypertensive
- Group 4: Healthy Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.