NCT04622683已完成不适用
Effects of Hepatic Ultrasound on Metabolic Homeostasis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 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
研究组 & 干预措施
Control Group- Healthy, Lean Individuals
Experimental
Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects.
干预措施: Ultrasound (Procedure)
Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance
Active Comparator
Determine whether three episodes of porta hepatic ultrasound exposure will affect plasma glucose levels as well as insulin sensitivity among overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance (as defined by OGTT.
干预措施: Ultrasound (Procedure)
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 (1)
Loading locations...
相似试验
招募中
不适用
Mechanisms of Ultrasound Neuromodulation Effects in DiabetesInsulin SensitivityNCT06042517Yale University77
已完成
不适用
Evaluation of Liver Disease With Elastography Measurements in Patients Undergoing Liver Transplant SurgeryLiver TransplantationNCT01890460Baylor Research Institute13
已完成
不适用
Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DMType 2 DiabetesNCT04502212General Electric Research16
已完成
不适用
The study of ultrasound findings and biochemical markers for the predicting congenital heart failure in recipients' infant in twin twin transfusion syndrome.pregnant women, twin twin transfusion syndromeJPRN-UMIN000028217Kawasaki Medical School Obstetrics and Gynecology50
撤回
不适用
Assessment of Fatty Liver With Thermo-acoustic DeviceNAFLDNon-alcoholic Fatty LiverNon-Alcoholic Fatty Liver DiseaseNon-alcoholic SteatohepatitisFatty Liver DiseaseNASHFatty LiverNCT04302051Medical College of Wisconsin75