Neuropeptide Y for High Blood Pressure

(OB-HTN Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Cardiovascular disease, Renal disease, Smoking, Diabetes

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Neuropeptide Y for high blood pressure?

Research suggests that Neuropeptide Y (NPY) can directly cause blood vessels to constrict, which might help control blood pressure. It also enhances the effects of other substances that affect blood pressure, indicating it could play a role in managing high blood pressure. ^{1 2 3 4 5}

Is Neuropeptide Y safe for use in humans?

Neuropeptide Y (NPY) is involved in controlling blood pressure and cardiovascular functions, but its safety in humans is not clearly established. It has direct effects on blood vessels and interacts with other substances that affect blood pressure, but more research is needed to understand its safety profile. ^{2 3 6 7 8}

How does the drug Neuropeptide Y differ from other treatments for high blood pressure?

Neuropeptide Y (NPY) is unique because it is a peptide that works by modulating the sympathetic nervous system, influencing blood pressure through its vasoconstrictor properties and interaction with other cardiovascular hormones. Unlike traditional blood pressure medications that often target adrenergic receptors, NPY acts independently of adrenergic activation, offering a novel mechanism for blood pressure control. ^{1 2 5 6 9}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 55 years old with a BMI under 30.

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.

Exclusion Criteria

People with diabetes are not allowed in the study.

I have a significant heart condition.

I have kidney disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physiological stress protocols and drug infusions to measure sympathetic nervous system activity and blood flow

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Neuropeptide Y (Neuropeptide)

Trial Overview 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.

Participant Groups

Group I: Obese-hypertensive Experimental Treatment 1 Intervention

Obese adults who are being treated for hypertension

Group II: Obese Experimental Treatment 1 Intervention

Obese adults who are not hypertensive

Group III: Hypertensive Experimental Treatment 1 Intervention

Hypertensive adults who are not obese

Group IV: Healthy Control Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas Southwestern Medical Center Dallas, TX

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

Findings from Research

Neuropeptide Y (NPY) is involved in regulating cardiovascular function and blood pressure, acting as a cotransmitter in sympathetic neurons and influencing responses in both the brain and peripheral tissues.

In hypertension, the effects of NPY may change, leading to increased vasoconstriction and potential contributions to the development of high blood pressure, suggesting it could be a target for future research and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropeptide Y: a possible role in hypertension? Michel, MC., Rascher, W.[2006]

Neuropeptide Y (NPY) has direct vasoconstrictor properties that can affect blood pressure independently of adrenergic activation, indicating its potential role in cardiovascular regulation.

NPY may enhance the effects of other substances that stimulate blood vessels and could influence blood pressure by regulating hormone release related to cardiovascular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of neuropeptide Y. Waeber, B., Aubert, JF., Corder, R., et al.[2019]

Patients with pregnancy-induced hypertension (PIH) had significantly higher plasma neuropeptide Y (NPY) levels compared to normal non-pregnant and normal pregnant women, indicating a potential link between elevated NPY and PIH.

After delivery, plasma NPY levels decreased in moderate and severe PIH patients, but levels remained elevated compared to normal non-pregnant women, suggesting that NPY may contribute to the persistence of hypertension even after pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Changes of plasma level of neuropeptide Y in patients with pregnancy induced hypertension]. Jin, L., Wang, C.[2006]

Genetically hypertensive rats (SHR) have higher levels of neuropeptide Y (NPY) in their platelets compared to normotensive rats (WKY), suggesting a genetic link to hypertension.

The study found that while NPY is released from platelets during aggregation with collagen, this release is significantly greater in hypertensive rats, indicating that NPY may play a role in vascular complications associated with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet neuropeptide Y in spontaneously hypertensive rats. Ogawa, T., Kitamura, K., Kangawa, K., et al.[2006]

In spontaneously hypertensive rats (SHR), there are higher levels of neuropeptide Y (NPY) in platelet-rich plasma compared to age-matched Wistar-Kyoto (WKY) rats, indicating a potential role of NPY in the development of hypertension.

As SHR age, their responsiveness to vasopressor agents like norepinephrine and NPY increases, suggesting that the mechanisms of hypertension may involve enhanced sympathetic activity and NPY release, particularly in younger SHR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of vascular function by neuropeptide Y during development of hypertension in spontaneously hypertensive rats. Zukowska-Grojec, Z., Golczynska, M., Shen, GH., et al.[2019]

In a study of 189 patients with end-stage renal disease (ESRD), those carrying the C allele of the NPY receptor Y2 gene had a significantly higher left ventricular mass index (LVMI), indicating a potential genetic risk factor for heart complications.

The research found that higher plasma levels of neuropeptide Y (NPY) were linked to increased LVMI specifically in patients with the C allele, suggesting that this genetic variation may enhance the impact of NPY on heart remodeling in ESRD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropeptide Y receptor Y2 gene polymorphism interacts with plasma neuropeptide Y levels in predicting left ventricular hypertrophy in dialysis patients. Testa, A., Mallamaci, F., Macrì, R., et al.[2010]

Neuropeptide Y (NPY) plays a significant role in regulating cardiovascular functions, and abnormalities in its release or receptor activity may lead to serious conditions like hypertension and heart failure.

The identification of different NPY receptor subtypes opens up the possibility for creating targeted treatments that could specifically address cardiovascular diseases by modulating these receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic potential of neuropeptide Y in cardiovascular disease. Hudspith, MJ., Munglani, R.[2019]

Neuropeptide Y (NPY) plays a significant role in regulating blood pressure by causing blood vessels to constrict and enhancing the effects of noradrenaline, while also inhibiting noradrenaline release, indicating its potential as a target for hypertension treatment.

The discovery of multiple NPY receptors (Y1, Y2, and Y3) and their varying responses to NPY and related peptides suggests that developing specific receptor antagonists could lead to new therapeutic strategies for managing conditions like primary hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple neuropeptide Y receptors are involved in cardiovascular regulation. Peripheral and central mechanisms. Grundemar, L., Håkanson, R.[2019]

Neuropeptide Y (NPY) is a key peptide involved in regulating blood pressure by modulating the sympathetic nervous system, highlighting its potential role in cardiovascular health.

The review discusses how NPY influences vascular tone and cardiac function through various mechanisms, suggesting its importance in understanding blood pressure control and potential therapeutic targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of neuropeptide Y in cardiovascular regulation. Walker, P., Grouzmann, E., Burnier, M., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Neuropeptide Y: a possible role in hypertension? [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of neuropeptide Y. [2019]

3. China pubmed.ncbi.nlm.nih.gov

[Changes of plasma level of neuropeptide Y in patients with pregnancy induced hypertension]. [2006]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Platelet neuropeptide Y in spontaneously hypertensive rats. [2006]

5. Germany pubmed.ncbi.nlm.nih.gov

Modulation of vascular function by neuropeptide Y during development of hypertension in spontaneously hypertensive rats. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Neuropeptide Y receptor Y2 gene polymorphism interacts with plasma neuropeptide Y levels in predicting left ventricular hypertrophy in dialysis patients. [2010]

7. England pubmed.ncbi.nlm.nih.gov

The therapeutic potential of neuropeptide Y in cardiovascular disease. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Multiple neuropeptide Y receptors are involved in cardiovascular regulation. Peripheral and central mechanisms. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The role of neuropeptide Y in cardiovascular regulation. [2019]