Na-Phenylbutyrate VAscular Trial

Early Phase 1

Not yet recruiting

• Conditions: Diabetes
• Interventions: Drug: Sodium Phenylbutyrate; Other: Placebo

• Registration Number: NCT06645769
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Study Start: 2025-05-01
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NaPB administration	Sodium Phenylbutyrate	-
Placebo control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Systemic vascular resistance	from enrollment to the end of participation at 8 weeks	Arterial hemodynamics and echocardiography to assess systemic vascular resistance, in dynes × sec/cm5.

Secondary Outcome Measures

Name	Time	Method
Plasma BCAAs	from enrollment to the end of participation at 8 weeks	Plasma branched chain amino acid levels, measured by mass spectrometry (in microMolar)
Flow-mediated dilation (FMD)	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 (%).
Carotid femoral pulse wave velocity (PWV)	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.