UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation

Completed

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT02178787

Run by

Beth Israel Deaconess Medical Center

People needed

60

Starts

2014-04-01

Expected to finish

2015-06-01

Last updated by the study team

2017-06-16

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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].

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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