Trial Outcomes & Findings for UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation (NCT NCT02178787)

NCT ID: NCT02178787

Last Updated: 2017-06-16

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: one year
• Results posted on: 2017-06-16

Participant Flow

Seventy four consented subjects, thirty type 2 diabetics and thirty non-diabetic controls completed the protocol. Screened participants that did not start the study: eleven were found ineligible after signing informed consent, two withdrew consent, one lost to follow up.

Participant milestones

Measure	Type 2 Diabetics Head-up tilt, vasoreactivity, sitting to standing-up	Non-diabetic Controls Head-up tilt, vasoreactivity, sitting to standing-up
Overall Study STARTED	35	39
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Measure	Type 2 Diabetics Head-up tilt, vasoreactivity, sitting to standing-up	Non-diabetic Controls Head-up tilt, vasoreactivity, sitting to standing-up
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study No TCD window	3	7
Overall Study Physician Decision	1	0

Baseline Characteristics

UTLight-transcranial Doppler Assessment of Regional Cerebral Autoregulation

Baseline characteristics by cohort

Measure	Type 2 Diabetics n=30 Participants Head-up tilt, vasoreactivity, sitting to standing-up	Non-diabetic Controls n=30 Participants Head-up tilt, vasoreactivity, sitting to standing-up	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 7.91 • n=5 Participants	66.31 years STANDARD_DEVIATION 9.95 • n=7 Participants	66.48 years STANDARD_DEVIATION 8.93 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Type 2 Diabetics n=30 Participants Head-up tilt, vasoreactivity, sitting to standing-up	Non-diabetic Controls n=30 Participants Head-up tilt, vasoreactivity, sitting to standing-up
To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).	28.23 cm/sec Standard Error 2.35	33.11 cm/sec Standard Error 1.54

SECONDARY outcome

Timeframe: one year

Population: The data analysis has determined that UT\_BF and UT\_OX signals were not reliable and required further algorithm modification and development during post processing (e.g. raw data signal to noise, signal averaging) that are beyond the scope of the study. Therefore, the results were inconsistent and inconclusive. No results to report.

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.

Outcome measures

Outcome data not reported

Adverse Events

Type 2 Diabetics

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Non-diabetic Controls

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Type 2 Diabetics n=30 participants at risk Head-up tilt, vasoreactivity, sitting to standing-up	Non-diabetic Controls n=30 participants at risk Head-up tilt, vasoreactivity, sitting to standing-up
Product Issues Headband pressure	6.7% 2/30 • 1 month	3.3% 1/30 • 1 month
Nervous system disorders Lightheadedness	0.00% 0/30 • 1 month	3.3% 1/30 • 1 month
Nervous system disorders Headache	3.3% 1/30 • 1 month	0.00% 0/30 • 1 month

Additional Information

Dr. Vera Novak

Beth Israel Deaconess Medical Center

Phone: 617-632-8680

Email: vnovak@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place