NCT04622683已完成不适用
Effects of Hepatic Ultrasound on Metabolic Homeostasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Insulin Resistance
研究概览
简要总结
The purpose of this study is to define the effect of ultrasound exposure of the liver in the region of the porta hepatis on glucose homeostasis and insulin resistance in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •18 - 60 years of age
- •Aim 1: Healthy lean men and women, BMI<24 kg/m2, with normal fasting glucose (blood glucose between 60 and 100mg/dl and normal glucose tolerance on OGTT (blood glucose <140 mg/dl at 2 hours post glucose challenge) at the screening visit.
- •Aim 2: Overweight and obese men and women, BMI 25 - 35 kg/m2
排除标准
- •Type 1 and type 2 diabetes
- •Surgery in the past 90 days
- •Previous surgery of the spleen or splenectomy, esophagus, lungs, stomach, duodenum, or liver
- •Recent traumatic injury, including intra-cerebral hemorrhage and visceral injury
- •End stage renal disease and/or uremia
- •Active malignancy
- •Previous leukemia and/or lymphoma
- •Human immunodeficiency virus infection or AIDS
- •Rheumatoid arthritis or other immune-mediated diseases (e.g. inflammatory bowel disease)
- •Arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, bradycardia, ventricular arrhythmias, and A-V block
- •Implanted pacemaker or cardioverter/defibrillator (AICD)
- •History of stable or unstable angina, myocardial infarction, angioplasty or coronary arterial by-pass grafting surgery
- •History of stroke or TIA
- •History of deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
- •Previous episodes of pancreatitis
- •Spinal disorders
- •Chronic pain syndromes
- •History of thrombosis or bleeding disorders
- •Stage III-IV pressure ulcers
- •Sickle cell anemia or other anemia syndromes
- •Monocytosis
- •Thrombocytopenia
- •Diagnosed with fever of unknown origin (FUO)
- •Previously or currently implanted vagus nerve stimulator
- •Previously or currently implanted spinal cord stimulator
- •Other chronically-implanted electronic medical device
- •History of seizures
- •History of cancer
- •Individuals who have taken any of the following medications within two weeks of receiving ultrasound delivery: anti-coagulant, anti-platelet, anti-inflammatory, immunosuppressive agents, alpha and/or beta adrenoceptor blocking agents, anti-seizure medications, anti-diabetic medication
- •Individuals with a substance abuse problem
- •Pregnant women
- •Ascites detected in the abdomen that may effect delivery of shear wave elastroghapy pulse
结局指标
主要结局
Insulin Resistance
时间窗: 1 week
Change in OGTT measurements after Hepatic Ultrasound
次要结局
未报告次要终点
研究者
研究点 (2)
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