UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation

NCT02178787 | Completed Results

• 1 other identifier: 2014P000027
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

cerebral blood flow; near infrared spectroscopy; transcranial Doppler; diabetes mellitus; cerebral autoregulation

Outcome Measures

Primary Outcomes (1)

• To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).

  CO2 reactivity will be measured as the slope of regression between TCD\_BFV and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.

  one year

Secondary Outcomes (1)

• To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox).

  one year

Study Arms (2)

Type 2 diabetes mellitus

Head-up tilt, vasoreactivity, standing up.

Non-diabetic controls

Head-up tilt, vasoreactivity, standing up.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population sample

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;

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Ornim Medical Ltd.: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The data analysis has determined that UT\_BF signal and UT\_OX signals were unreliable and require further development on monitoring algorithm. No results to be reported.

Results Point of Contact

• Title: Dr. Vera Novak
• Organization: Beth Israel Deaconess Medical Center

vnovak@bidmc.harvard.edu

617-632-8680

Study Officials

• Vera Novak, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director SAFE laboratory, Associate Professor of Neurology

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-04

Locations

US (1)