Diabetes MellitusTBINCT02020850
Young Toe-Brachial Index Assessment
An observational study of Diabetes Mellitus and Coronary Artery Disease,, run by University of British Columbia at 1 site in Canada.
Trial summary
The Toe-Brachial Index (TBI) that has been using in our laboratory is 0.6, but the average value we measured in normal individuals is about 1.0, furthermore, we can not find out the reference of TBI that is currently being used. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Coronary Artery Disease,, Vascular Diseases
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from the classes of Faculty of Medicine in the University of British Columbia
Who may be able to join
- All students from the University of British Columbia, Faculty of Medicine graduating class of 2017
Who cannot join
- Students who declined to participate in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
York N Hsiang, MB FRCSC, 604 876 5882, York.Hsiang@vch.ca
Whitney Quong, 604 809 7293, wquong@alumni.ubc.ca
About this study
Official title: Determining the Normal Toe-Brachial Index in Young Adults
The Toe-Brachial Index (TBI) that has been using in our laboratory is 0.6, but the average value we measured in normal individuals is about 1.0, furthermore, we can not find out the reference of TBI that is currently being used. The purpose of this study is to determine the more accurate value of TBI and Ankle-Brachial Index (ABI). In this study, all participants will be required to fill out a demographic questionnaire before the blood pressures test. All participants will have their toe, ankle and brachial systolic blood pressure measurements to obtain the TBI and ABI.
Read the detailed description
All participants will fill out a demographic questionnaire that includes:
- Race, gender, age
- Height and weight
- Perceived stress level (potentially measured using Cohen's Perceived Stress scale(PSS))
- Activity level, with description hours per week, cardio versus non-cardio, and intensity (mild, moderate, intense)
- Smoking history, alcohol consumption, caffeine intake, and drug use (recreational, medicine - over - the - counter and prescription, including birth control pills)
- Hand dominance, and leg dominance
- Past medical history - with emphasis on cardiovascular disease (hypertension, cancer, coronary heart disease, diabetes mellitus, high cholesterol, coagulopathies, previous thromboses) as well as renal, adrenal, and thyroid disorders, Raynaud's phenomenon
- Family medical history (cancer, coronary heart disease, diabetes mellitus, high cholesterol)
Participants with known existing diabetes, coronary artery disease, or a history of vascular disease will be included in the study; nevertheless, their results may be analyzed in a separate cohort for comparison against those undiagnosed with the aforementioned condition.
The TBI (Toe - Brachial Index) will be measured by the following procedure.
- The assessment time and room temperature will be recorded
- The participant should lay supine for a minimum of five minutes in a warm and comfortable room
- Select the appropriate cuff for each upper arm and each large toe and separately placed them around the arm and large toe.
- The blood pressure measurements will be performed with photo plethysmography (PPS) and chart recorder. The phototransducer is connected to the PPS, and the digit cuff is connected to an aneroid sphygmomanometer.
- The toe and ipsilateral arm systolic blood pressures will be measured up to three times for accuracy.
- The TBI will be calculated by dividing the averaged toe systolic blood pressure, by the averaged brachial systolic blood pressure.
The ABI (Ankle - Brachial Index) will be measured by the following procedure.
- The blood pressure cuff will be placed proximal to the malleoli and ultrasound gel cover the skin overlying the dorsalis pedis and posterior tibial arteries in the foot.
- The dorsalis pedis and posterior tibial arteries blood pressure will be measured by using hand-held Doppler probe.
- The ankle systolic blood pressure will be taken as the higher pressure of the 2 arteries at the ankle.
- The ABI will be calculated by dividing the ankle systolic blood pressure, by the averaged brachial systolic blood pressure.
The brachial, toe and ankle blood pressures will be measured on the opposite limbs, and the TBI and ABI will be calculated following the protocol outlined above.
- Keywords
- Toe-Brachial Index, Ankle-Brachial Index, Systolic blood pressure
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease, Vascular Diseases
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 |
|---|---|---|
| Toe-Brachial and Ankle-Brachial Index | toe systolic blood pressure, ankle systolic blood pressure, brachial systolic blood pressure test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toe-Brachial Index
The toe and ipsilateral brachial systolic blood pressures will be measured on both side of limbs. The participant should be fully-supported, comfortable, warm with arms and legs at heart level.
Measured: Minimum 5 minutes post participant lying supine
Secondary outcomes (1)
Ankle-Brachial Index
The ankle and ipsilateral brachial systolic blood pressures will be measured on both side of limbs. The participant should be fully-supported, comfortable, warm with arms and legs at heart level.
Measured: Minimum 5 minutes post participant lying supine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- York N Hsiang, MB FRCSC, Principal investigator, UBC, Division of Vascular Surgery and Vancouver General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020850
- Sponsor's protocol ID
- H13-03144
- Acronym
- TBI
- Status last verified
- Jul 2014
- First submitted
- 19 Dec 2013
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Quong WL, Fung AT, Yu RY, Hsiang YN. Reassessing the normal toe-brachial index in young healthy adults. J Vasc Surg. 2016 Mar;63(3):652-6. doi: 10.1016/j.jvs.2015.09.019.
PubMed 26916582
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Normal Toe-Brachial Index in Young Adults
- ClinicalTrials.gov ID
- NCT02020850
- Acronym / sponsor ID
- TBI / H13-03144
- Keywords
- Toe-Brachial Index, Ankle-Brachial Index, Systolic blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Toe-Brachial Index (TBI) that has been using in our laboratory is 0.6, but the average value we measured in normal individuals is about 1.0, furthermore, we can not find out the reference of TBI that is currently being used. The purpose of this study is to determine the more accurate value of TBI and Ankle-Brachial Index (ABI). In this study, all participants will be required to fill out a demographic questionnaire before the blood pressures test. All participants will have their toe, ankle and brachial systolic blood pressure measurements to obtain the TBI and ABI.
Detailed description
All participants will fill out a demographic questionnaire that includes:
- Race, gender, age
- Height and weight
- Perceived stress level (potentially measured using Cohen's Perceived Stress scale(PSS))
- Activity level, with description hours per week, cardio versus non-cardio, and intensity (mild, moderate, intense)
- Smoking history, alcohol consumption, caffeine intake, and drug use (recreational, medicine - over - the - counter and prescription, including birth control pills)
- Hand dominance, and leg dominance
- Past medical history - with emphasis on cardiovascular disease (hypertension, cancer, coronary heart disease, diabetes mellitus, high cholesterol, coagulopathies, previous thromboses) as well as renal, adrenal, and thyroid disorders, Raynaud's phenomenon
- Family medical history (cancer, coronary heart disease, diabetes mellitus, high cholesterol)
Participants with known existing diabetes, coronary artery disease, or a history of vascular disease will be included in the study; nevertheless, their results may be analyzed in a separate cohort for comparison against those undiagnosed with the aforementioned condition.
The TBI (Toe - Brachial Index) will be measured by the following procedure.
- The assessment time and room temperature will be recorded
- The participant should lay supine for a minimum of five minutes in a warm and comfortable room
- Select the appropriate cuff for each upper arm and each large toe and separately placed them around the arm and large toe.
- The blood pressure measurements will be performed with photo plethysmography (PPS) and chart recorder. The phototransducer is connected to the PPS, and the digit cuff is connected to an aneroid sphygmomanometer.
- The toe and ipsilateral arm systolic blood pressures will be measured up to three times for accuracy.
- The TBI will be calculated by dividing the averaged toe systolic blood pressure, by the averaged brachial systolic blood pressure.
The ABI (Ankle - Brachial Index) will be measured by the following procedure.
- The blood pressure cuff will be placed proximal to the malleoli and ultrasound gel cover the skin overlying the dorsalis pedis and posterior tibial arteries in the foot.
- The dorsalis pedis and posterior tibial arteries blood pressure will be measured by using hand-held Doppler probe.
- The ankle systolic blood pressure will be taken as the higher pressure of the 2 arteries at the ankle.
- The ABI will be calculated by dividing the ankle systolic blood pressure, by the averaged brachial systolic blood pressure.
The brachial, toe and ankle blood pressures will be measured on the opposite limbs, and the TBI and ABI will be calculated following the protocol outlined above.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toe-Brachial and Ankle-Brachial Index | – | –toe systolic blood pressure, ankle systolic blood pressure, brachial systolic blood pressure test |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from the classes of Faculty of Medicine in the University of British Columbia
Key inclusion criteria (1 listed)
- All students from the University of British Columbia, Faculty of Medicine graduating class of 2017
Key exclusion criteria (1 listed)
- Students who declined to participate in the study
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
Toe-Brachial Index
Time frame: Minimum 5 minutes post participant lying supine
The toe and ipsilateral brachial systolic blood pressures will be measured on both side of limbs. The participant should be fully-supported, comfortable, warm with arms and legs at heart level.
1 secondary outcome
Ankle-Brachial Index
Time frame: Minimum 5 minutes post participant lying supine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- Derived from this study: PubMed 26916582Quong WL, Fung AT, Yu RY, Hsiang YN. Reassessing the normal toe-brachial index in young healthy adults. J Vasc Surg. 2016 Mar;63(3):652-6. doi: 10.1016/j.jvs.2015.09.019.
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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.
York N Hsiang, MB FRCSC principal investigator
UBC, Division of Vascular Surgery and Vancouver General Hospital
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 Mellitus and Coronary Artery Disease,, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Jul 2014. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact York N Hsiang, MB FRCSC (604.876.5882, york.hsiang@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toe-Brachial Index (time frame: Minimum 5 minutes post participant lying supine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020850, which also lists 1 linked publication.
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 4 Jul 2014.