Arginase Inhibition and Endothelial Function in Humans With Obesity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Endothelium-dependent change in forearm blood flow
研究概览
简要总结
To evaluate the efficacy of arginase inhibition on endothelial function in humans with obesity.
详细描述
The study is performed on one group of subjects with body mass index >35 and the absence of type 2 diabetes.
Inclusion criteria:
Body mass index >35 kg/m2.
Exclusion criteria:
Age >80 years. Type 2 diabetes defined as >7 mmol/L in fasting plasma glucose or >11 mmol/L following 2h of oral glycemic load.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >35kg/m2
排除标准
- •Age >80 years. Type 2 diabetes defined as >7 mmol/L in fasting plasma glucose or >11 mmol/L following 2h of oral glycemic load.
- •Myocardial infarction/unstable angina within 6 weeks prior to the study. Treatment with oral anticoagulants (Warfarin or New oral anticoagulants), Raynaud's phenomenon, peripheral vasculopathies, arterial shunting or other vascular surgery of the study arm.
- •Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
- •Participant in an ongoing study. Unwillingness to participate following oral and written information.
研究组 & 干预措施
Arginase inhibition
Endothelium dependent and -independent vasodilatation before and after 120min intra-arterial administration of arginase the inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA) is started and is maintained for 120 min at a rate of 0.1 mg/min
干预措施: Nω-hydroxy-nor-arginine (Drug)
结局指标
主要结局
Endothelium-dependent change in forearm blood flow
时间窗: 120 min intraarterial infusion of the arginase inhibitor nor-NOHA
Percentage change in forearm blood flow from baseline induced by the endothelium-dependent vasodilator serotonin during arginase blockade vs. saline.
次要结局
- Endothelium-independent change in forearm blood flow(120 min intraarterial infusion of the arginase inhibitor nor-NOHA)
研究者
John Pernow
Professor
Karolinska Institutet