Diabetes
Conditions
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.
Interventions
DRUGSodium Phenylbutyrate
will be compared to placebo
OTHERPlacebo
will be compared to NaPB
Sponsors
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTClaire Brady
PRINCIPAL_INVESTIGATORZoltan Arany, MDPHD
University of Pennsylvania
Outcome results
None listed