Na-Phenylbutyrate VAscular Trial (NAPVAT)

University of Pennsylvania

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Diabetes

Treatments: Drug: Sodium Phenylbutyrate; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06645769

R01HL152446 (U.S. NIH Grant/Contract)

NAPVAT

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

NaPB administration

Experimental group

Treatment:

Drug: Sodium Phenylbutyrate

Placebo control

Placebo Comparator group

Treatment:

Other: Placebo