NCT06645769尚未招募1 期
Na-Phenylbutyrate VAscular Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Systemic vascular resistance
研究概览
简要总结
This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age and less than
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo control
Placebo Comparator
干预措施: Placebo (Other)
NaPB administration
Experimental
干预措施: Sodium Phenylbutyrate (Drug)
结局指标
主要结局
Systemic vascular resistance
时间窗: from enrollment to the end of participation at 8 weeks
Arterial hemodynamics and echocardiography to assess systemic vascular resistance, in dynes × sec/cm5.
次要结局
- Plasma BCAAs(from enrollment to the end of participation at 8 weeks)
- Flow-mediated dilation (FMD)(from enrollment to the end of participation at 8 weeks)
- Carotid femoral pulse wave velocity (PWV)(from enrollment to the end of participation at 8 weeks)
研究者
相似试验
撤回
不适用
Impact of Clinical, Demographic and Laboratory Variables on Brain Natriuretic Peptide LevelsHeart FailureSepsisNCT01382394Rambam Health Care Campus60
终止
1 期
Clinical Trial of Sodium Phenylbutyrate in Children With Spinal Muscular Atrophy Types II or IIISpinal Muscular Atrophy Type IISpinal Muscular Atrophy Type IIINCT00439569Westat9
终止
1 期
Clinical Trial of Sodium Phenylbutyrate in Children With Spinal Muscular Atrophy Type ISpinal Muscular Atrophy Type INCT00439218Westat5
已完成
4 期
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of HypertensionPre-hypertensionHypertensionNCT01202175University of California, San Diego50
已完成
2 期
Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle DisordersAmino Acid Metabolism, Inborn ErrorsNCT00004767National Center for Research Resources (NCRR)20