N/A
N=74
UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02178787 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV). — 28.23; 33.11 cm/sec
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV). |
28.23; 33.11 | — |
| SECONDARY To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox). |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
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 130/85 mm Hg and/or treated for hypertension].
Control group:
- This group will be non-diabetic (normal fasting blood glucose and HbA1c 130/85 mm Hg and/or treated for hypertension].
Exclusion Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02178787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.