Not yet recruiting NCT06645769
Na-Phenylbutyrate VAscular Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Phenylbutyrate, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Sodium Phenylbutyrate
will be compared to placebo - Other Placebo
will be compared to NaPB
Primary outcome measures
- Systemic vascular resistance [Time frame: from enrollment to the end of participation at 8 weeks]
Secondary outcome measures (3)
- Plasma BCAAs [Time frame: from enrollment to the end of participation at 8 weeks]
- Flow-mediated dilation (FMD) [Time frame: from enrollment to the end of participation at 8 weeks]
- Carotid femoral pulse wave velocity (PWV) [Time frame: from enrollment to the end of participation at 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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 PMID 36223763
- 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. PMID 35717342
Identifiers
NCT: NCT06645769 · NAPVAT · R01HL152446