Na-Phenylbutyrate VAscular Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment Of Vascular Health After Niacin Therapy (AVANT)

NCT02003638

Coronary Artery Disease Carotid Artery Disease Peripheral Artery Disease

COMPLETED NA

NK-1 Antagonism of SLV317 in Humans

NCT00160862

Healthy

COMPLETED PHASE1

Effects of Tetrahydrobiopterin (BH4) on Leg Blood Flow and Exercise Capacity in Patients With Peripheral Artery Disease

NCT03493412

Peripheral Artery Disease Peripheral Arterial Disease

WITHDRAWN PHASE4

Effect of Dapagliflozin on Microvascular Function in Women With Symptoms of Coronary Artery Disease

NCT05762952

Myocardial Ischemia

RECRUITING PHASE1

NAD Supplementation and Vascular Health in PAD

NCT06534944

Peripheral Artery Disease

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NaPB administration

Group Type EXPERIMENTAL

Sodium Phenylbutyrate

Intervention Type DRUG

will be compared to placebo

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

will be compared to NaPB

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Phenylbutyrate

will be compared to placebo

Intervention Type DRUG

Placebo

will be compared to NaPB

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Over 18 years of age and less than 60.
* Healthy subjects will have no history of diabetes or prediabetes.
* Diabetes subjects can be either insulin dependent or not.
* Able to provide written consent and to comply with the procedures of the study protocol.

Exclusion Criteria

* Age \<18 or \>60
* Pregnant or lactating women.
* Subjects with hypertension or taking any vasodilatory medications, any steroidal drugs, haloperidol, or valproic acid.
* Patients with congestive heart failure, severe renal insufficiency, hepatic failure, or known sodium retention with oedema.
* Active alcohol or substance abuse.
* Use of tobacco within the previous six months.
* Unble to provide written consent and to comply with the procedures of the study protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes