Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL152446 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaPB administration | Experimental |
| |
| Placebo control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Phenylbutyrate | Drug | will be compared to placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic vascular resistance | Arterial hemodynamics and echocardiography to assess systemic vascular resistance, in dynes × sec/cm5. | from enrollment to the end of participation at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma BCAAs | Plasma branched chain amino acid levels, measured by mass spectrometry (in microMolar) | from enrollment to the end of participation at 8 weeks |
| Flow-mediated dilation (FMD) | 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 (%). |
| Measure | Description | Time Frame |
|---|---|---|
| Home ambulatory mean pressure and pulse pressure | At home blood pressure cuff used to determine changes in blood pressure with normal activities (mmHg) | from enrollment to the end of participation at 8 weeks |
| Cardiac Ejection Fraction |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Brady | Contact | 8573344274 | Claire.Brady@Pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zoltan Arany, MDPHD | University of Pennsylvania | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36223763 | Background | Murashige D, Jung JW, Neinast MD, Levin MG, Chu Q, Lambert JP, Garbincius JF, Kim B, Hoshino A, Marti-Pamies I, McDaid KS, Shewale SV, Flam E, Yang S, Roberts E, Li L, Morley MP, Bedi KC Jr, Hyman MC, Frankel DS, Margulies KB, Assoian RK, Elrod JW, Jang C, Rabinowitz JD, Arany Z. Extra-cardiac BCAA catabolism lowers blood pressure and protects from heart failure. Cell Metab. 2022 Nov 1;34(11):1749-1764.e7. doi: 10.1016/j.cmet.2022.09.008. Epub 2022 Oct 11. | |
| 35717342 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C075773 | 4-phenylbutyric acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
will be compared to NaPB |
|
| from enrollment to the end of participation at 8 weeks |
| Carotid femoral pulse wave velocity (PWV) | 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. | from enrollment to the end of participation at 8 weeks |
echocardiography will be used to determine ejection fraction (%)
| from enrollment to the end of participation at 8 weeks |
| Vanweert F, Neinast M, Tapia EE, van de Weijer T, Hoeks J, Schrauwen-Hinderling VB, Blair MC, Bornstein MR, Hesselink MKC, Schrauwen P, Arany Z, Phielix E. A randomized placebo-controlled clinical trial for pharmacological activation of BCAA catabolism in patients with type 2 diabetes. Nat Commun. 2022 Jun 18;13(1):3508. doi: 10.1038/s41467-022-31249-9. |