DiabetesUTLightNCT02178787
UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation
An observational study of Diabetes, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population sample
Who may be able to join
- 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:
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- 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].
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
Read the detailed description
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.
The investigators hypothesize that:
- UT_BF will accurately track TCD_BFV in responses in the anterior circulation (ACA and/or MCA territory) to blood pressure changes, hypercapnia and hypocapnia challenges in healthy older people.
- UT_BF may be more sensitive to detect abnormalities in regional perfusion in diabetic adults as compared to healthy controls and compared to TCD_BFV. (UT_Ox) may provide a new indicator to identify older diabetic adults with brain tissue hypoxia during orthostatic challenges that may be at greater risk of brain damage of cognitive decline that will be derived from a change in tissue oxygenation upon standing up that is not routinely evaluated by TCD. Outcomes: Primary outcome is the sensitivity and specificity of UT_BF and TCD_BFV to blood pressure and CO2 challenges, defined as percent change of UT_BF and TCD_BFV in response to hypercapnia and hypocapnia challenges. Secondary outcomes are the differences in cerebral blood flow measured by UT_BF, TCD_BFV between healthy old and diabetic subjects during postural changes. Third outcomes are differences in UT_Ox between healthy old and diabetic subjects.
- Conditions
- Diabetes
- Keywords
- cerebral blood flow, near infrared spectroscopy, transcranial Doppler, diabetes mellitus, cerebral autoregulation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes mellitus | Head-up tilt, vasoreactivity, standing up. | |
| Non-diabetic controls | Head-up tilt, vasoreactivity, standing up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox).
CO2 reactivity will be measured as the slope of regression between UT_BF or UT_Ox and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ornim Medical Ltd.
- Responsible party
- Principal investigator, Vera Novak, Beth Israel Deaconess Medical Center
- Investigators
- Vera Novak, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178787
- Sponsor's protocol ID
- 2014P000027
- Acronym
- UTLight
- Status last verified
- Apr 2017
- First submitted
- 27 Jun 2014
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation
- ClinicalTrials.gov ID
- NCT02178787
- Acronym / sponsor ID
- UTLight / 2014P000027
- Conditions
- Diabetes
- Keywords
- cerebral blood flow, near infrared spectroscopy, transcranial Doppler, diabetes mellitus, cerebral autoregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Ornim Medical Ltd.
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators hypothesize that:
- UT_BF will accurately track TCD_BFV in responses in the anterior circulation (ACA and/or MCA territory) to blood pressure changes, hypercapnia and hypocapnia challenges in healthy older people.
- UT_BF may be more sensitive to detect abnormalities in regional perfusion in diabetic adults as compared to healthy controls and compared to TCD_BFV. (UT_Ox) may provide a new indicator to identify older diabetic adults with brain tissue hypoxia during orthostatic challenges that may be at greater risk of brain damage of cognitive decline that will be derived from a change in tissue oxygenation upon standing up that is not routinely evaluated by TCD. Outcomes: Primary outcome is the sensitivity and specificity of UT_BF and TCD_BFV to blood pressure and CO2 challenges, defined as percent change of UT_BF and TCD_BFV in response to hypercapnia and hypocapnia challenges. Secondary outcomes are the differences in cerebral blood flow measured by UT_BF, TCD_BFV between healthy old and diabetic subjects during postural changes. Third outcomes are differences in UT_Ox between healthy old and diabetic subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes mellitus | – | –Head-up tilt, vasoreactivity, standing up. |
| Non-diabetic controls | – | –Head-up tilt, vasoreactivity, standing up. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population sample
Key inclusion criteria (11 listed)
- 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].
- This group will be non-diabetic (normal fasting blood glucose and HbA1c < 6.5%).
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).
Time frame: 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.
1 secondary outcome
To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox).
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Novak, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV). (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.