UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).
研究概览
简要总结
Cerebral autoregulation (CA) is a complex mechanism that serves the essential and vital purpose of controlling cerebral blood flow and metabolism. A stable and optimal brain blood flow is imperative for normal brain function. Diabetes Mellitus (DM ) is associated with microvascular disease that alters CA and also with autonomic failure that may lead to orthostatic hypotension (OH). These conditions may lead to decreased brain blood flow in upright position. This observational study will compare two technologies that evaluate brain blood flow during standing up and other maneuvers in people with and without type 2 diabetes. These technologies are transcranial Doppler and UTLight technology (CerOx). This study will determine the safety and feasibility of CerOx technology for continuous monitoring of cerebral blood flow.
详细描述
Cerebral autoregulation (CA) is a complex mechanism that serves the essential and vital purpose of controlling cerebral blood flow and metabolism. A stable and optimal brain blood flow is imperative for normal brain function; therefore normal function of CA is crucial for brain health. Diabetes mellitus (DM) is associated with microvascular disease and abnormal autoregulation, which increases risk for stroke and death. Failure of CA has serious consequences across the lifespan and, in terms of prevalence adverse outcomes related to failing CA are most prominent in the elderly with diabetes.
Older diabetic adults often suffer from hypotension or fainting upon standing-up and may have abnormal CA. With abnormal CA, cerebral perfusion and tissue oxygenation declines upon standing up. Abnormalities in perfusion regulation in older people, and particularly those with diabetes may accelerate progression of brain atrophy resulting in cognitive decline, vascular dementia or Alzheimer's disease.
UTLight technology (CerOx), provides a new tool for evaluation of regional blood flow and oxygenation in cortical microvasculature, which is lacking in clinical medicine and patient care. UTLight may become a novel tool that would provide an easy and reliable assessment of regional perfusion and CA in specific cortical areas in health and disease that can be widely implemented in outpatient clinics. This is a pilot, observational feasibility study to compare blood flow measurements using UTLight and TCD.
Aim 1: To assess the safety and feasibility of UTLight for evaluation of regional cerebral blood flow regulation in the anterior circulation ((ACA) and/or middle cerebral artery (MCA) territories) in 20 non-diabetic adults >50 yrs old and 40 age-matched adults with type 2 diabetes.
Aim 2: To compare the profiles of UTLight blood flow (UT_BF), regional oximetry (UT_Ox) and TCD-blood flow velocities (TCD_BFV) in response to: 1) blood pressure changes induced by the postural change from supine to head-up tilt, and from sitting to standing-up; and 2) vasodilatation and vasoconstriction responses induced by hypercapnia and hypocapnia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetes group:
- •This group will consist of 40 men and women aged 50-85 years
- •diagnosed with type 2 DM and
- •treated with oral agents and/or combinations with insulin for at least one year,
- •either normotensive [BP <135/85 mm Hg and no medical history of hypertension) or hypertensive [BP >130/85 mm Hg and/or treated for hypertension].
- •Control group:
- •This group will be non-diabetic (normal fasting blood glucose and HbA1c < 6.5%).
- •This group will consist of 20 men and women matched with the diabetes group by age ±5 years, and
- •subjects will be normotensive [BP <130/85 mm Hg and
- •no medical history of hypertension] and
- •hypertensive [BP >130/85 mm Hg and/or treated for hypertension].
排除标准
- •Persons with any one of the following conditions will be excluded:
- •type I diabetes;
- •any unstable or acute medical condition;
- •myocardial infarction or major surgery within 6 months;
- •history of a major stroke;
- •dementia (by history) or inability to follow details of the protocol or MMSE < 20;
- •carotid stenosis > 80% by medical history, Doppler ultrasound, or MR angiography;
- •hemodynamically significant valvular disease;
- •clinically significant arrhythmias;
- •liver or renal failure or transplant;
- •severe hypertension [systolic BP >200 and/or diastolic BP >110 mm Hg or subjects taking ≥3 antihypertensive medications];
- •seizure disorders;
- •malignant tumors;
- •current recreational drug or alcohol abuse;
- •active smoking;
- •morbid obesity (BMI >40).
- •Women in both groups will be required to be postmenopausal.
- •TCD exclusion criteria - poor insonation window and TCD signal;
- •UT_Light exclusion- poor signal.
结局指标
主要结局
To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).
时间窗: one year
CO2 reactivity will be measured as the slope of regression between TCD_BFV and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.
次要结局
- To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox).(one year)
研究者
Vera Novak
Director SAFE laboratory, Associate Professor of Neurology
Beth Israel Deaconess Medical Center