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NCT Number: NCT06645769

Na-Phenylbutyrate VAscular Trial

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Phenylbutyrate

Drug

will be compared to placebo

Placebo

Other

will be compared to NaPB

Primary outcomes

  1. Systemic vascular resistance

    Time frame: from enrollment to the end of participation at 8 weeks

    Arterial hemodynamics and echocardiography to assess systemic vascular resistance, in dynes × sec/cm5.

Secondary outcomes

  1. Plasma BCAAs

    Time frame: from enrollment to the end of participation at 8 weeks

    Plasma branched chain amino acid levels, measured by mass spectrometry (in microMolar)

  2. Flow-mediated dilation (FMD)

    Time frame: from enrollment to the end of participation at 8 weeks

    FMD is a non-invasive test that measures the endothelial function of blood vessels. FMD is measured as a percentage increase in the diameter of an artery during hyperemia (%).

  3. Carotid femoral pulse wave velocity (PWV)

    Time frame: from enrollment to the end of participation at 8 weeks

    Pulse wave velocity (PWV) is the distance a pulse wave travels in a specific arterial segment divided by the time it takes to travel that distance (units: m/sec). PWV is a marker of cardiovascular risk.

Other outcomes

  1. Home ambulatory mean pressure and pulse pressure

    Time frame: from enrollment to the end of participation at 8 weeks

    At home blood pressure cuff used to determine changes in blood pressure with normal activities (mmHg)

  2. Cardiac Ejection Fraction

    Time frame: from enrollment to the end of participation at 8 weeks

    echocardiography will be used to determine ejection fraction (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Brady

CONTACT

[email protected]

8573344274

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: NAPVAT

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Oct 17, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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