DiabetesNCT03378024
Evaluate the Correlation of NIRS, ABI, Exercise, baPWV and Albuminuria With Peripheral Artery Occlusion Disease (PAD) and Other Atherosclerosis Outcomes
An observational study of Diabetes and Peripheral Arterial Occlusive Disease, run by Chang Gung Memorial Hospital.
Trial summary
By utilizing Near infrared spectroscopy (NIRS), the local blood flow, tissue oxygenation (StO2), and recovery time of ischemic leg; can be determined. It is reasonable to standardize an easy, simple and safe Active Pedal Plantarflexion (APP) exercise test working load which can achieve the lowest StO2 and other… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Peripheral Arterial Occlusive Disease
- What is being tested?
- oscillometric (Omron Colin co)
- Type of treatment
- Medical device
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 30 Apr 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nonpregnant \& ≥ 20 years old type1 and type 2 diabetic patients
Who may be able to join
- type 1 diabetic patients
- type 2 diabetic patients
Who cannot join
- Pregnancy
- Critical limb ischemia (gangrene change)
- A permanent pacemaker implant
- Systolic BP ≥ 200 mmHg or diastolic BP ≥100 mmHg
- Symptomatic orthostatic blood pressure drop ≥ 20 mmHg
- Severe critical aortic stenosis
Show all 13Show fewer
- Acute medical illness, fever, systemic infection
- Uncontrolled atrial or ventricular dysrhythmias
- Uncontrolled sinus tachycardia≥ 120/min
- Peripheral venous insufficiency, thrombosis or thrombophlebitis
- Those who has factors known to influence the PWV
- The brachial-ankle PWV could not be measured on the right and left sides
- Orthopedic condition (ankle or foot) that cannot perform an active pedal plantar flexion (APP) technique (arthritis, hemiparesis, balance impairment etc.)
About this study
Official title: To Evaluate the Correlation of Near Infrared Spectroscopy, ABI, Exercise Test, baPWV and Microalbuminuria With Peripheral Artery Occlusion Disease and Other Atherosclerosis Outcome
By utilizing Near infrared spectroscopy (NIRS), the local blood flow, tissue oxygenation (StO2), and recovery time of ischemic leg; can be determined. It is reasonable to standardize an easy, simple and safe Active Pedal Plantarflexion (APP) exercise test working load which can achieve the lowest StO2 and other parameters in ischemic leg through observation of NIRS. After standardized of an effective APP test, a determination of a new cutoff value of resting ABI in diagnosing PAD can probably be searched. Analysing the correlation of baPWV with ABI, atherosclerosis risk factors and parameters with atherosclerosis outcome. Observation the Sequential changes of baPWV, ABI and microalbuminuria after managing the atherosclerosis risks, and analyze their influence on the outcome of PAD, coronary artery disease(CAD) and cerebral vascular disease(CVA) outcomes.
Read the detailed description
Exercise testing by Active Pedal Plantar flexion:
The investigators plan to collect 140 cases:
- Healthy subjects with no apparent atherosclerotic risk [< 65 y/o, no diabetic mellitus (DM), no hypertension, or no hyperlipidemia, not obese, not current smoker, no smoking history >10 years] 4(n=5)
- Patients at risks (e.g. hypertension, hyperlipidemia) (n=5) but without DM,
- Type 1 and Type 2 DM patients with normal ABI( >1.0)and normal Toe-brachial index (TBI) (> 0.6) without intermittent claudication(by Edinburgh claudication questionnaire), nor PAD diagnosis (n= 10)
- DM normal ABI>1.0 and normal TBI (> 0.6) with suspected symptoms (intermittent claudication, non healing ulcer) (n=10),
- DM normal or borderline ABI( >1, 0.91~0.99) but low TBI (< 0.6), or with suspected symptoms (intermittent claudication, non healing ulcer) (n=20),
- DM patients with borderline ABI (0.91-0.99) (n=50) with or without leg symptoms,
- DM patients abnormal Low ABI (<0.9) (n=30) with or without leg symptoms,
- DM patients abnormal high ABI (> 1.3) (n=10)with or without leg symptoms, Post-exercise ABI with APP, and NIRS examination during APP exercise test will be performed.
The investigators also plan to collect 500 cases of nonpregnant, ≥ 40 years old DM patients, obtained baPWV and the resting ABI by oscillometric device (Omron colin, Japan). The investigators will apply this novel technique to assess the extent of arteriosclerosis and atherosclerosis by oscillometric device in our DM patient without PAD (ABI >0.9).
Collect baseline characteristics and follow up annual data: Age, sex, body weight, height, BMI, waist circumferences, history of smoking (ex-smoker, current), coexisting hypertension, hyperlipidemia, DM duration, presence of chronic DM complications of neuropathy, retinopathy (by fundus camera), nephropathy (cr, estimate glomerular filtration rate(eGFR), proteinuria, microalbuminuria). The biochemistry data involving atherosclerotic risk including: systolic blood pressure, diastolic pressure, mean pulse pressure, HbA1c, total cholesterol, LDL-Cholesterol(LDL-C), HDL-Cholesterol(HDL-C), triglyceride, creatinine, microalbuminuria,, high sensitive C-Reactive Protein (hs CRP), baseline EKG all will be collected. All the above data will be followed up annually for 3 years to analyze the correlation of progressive change of baPWV, ABI and microalbuminuria with the atherosclerosis event and mortality.
- Conditions
- Diabetes, Peripheral Arterial Occlusive Disease
- Being tested
- oscillometric (Omron Colin co)
- Keywords
- Oscillometric device, repetitive Active Pedal Plantarflexion (APP) exercise test, brachial-ankle pulse wave velocity (baPWV)
- Medical subject headings
- Diabetes Mellitus, Peripheral Arterial Occlusive Disease 1, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oscillometric (Omron Colin co)Device
fast measurements of the brachial-ankle pulse wave velocity (baPWV) and the resting ankle-brachial index(ABI) with the oscillometric method (Omron Colin co, Japan)
| Study group | Role | What they receive |
|---|---|---|
| diabetic mellitus patients | Measure the brachial-ankle pulse wave velocity (baPWV) and the resting ankle-brachial index(ABI) of pre-exercise and post-exercise by the oscillometric (Omron Colin co.).
And follow up for 3 years to identify of the correlation with PAD outcome. Receives: Device: oscillometric (Omron Colin co) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the correlation between NIRS and ABI
Analyse the correlation of NIRS with different ABI
Measured: 12 month
Defined APP exercise ABI criteria for PAD diagnosis
Design APP exercise with effective working load to defined ABI criteria for PAD diagnosis
Measured: 12 month
The correlation of changes of baPWV and the outcome of PAD
Analyse the sequential changes of baPWV and the outcome of PAD
Measured: 12,24 and 36 months
The correlation of changes of exercise ABI and the outcome of PAD
Analyse the sequential changes of exercise ABI and the outcome of PAD
Measured: 12,24 and 36 months
The correlation of changes of albuminuria and the outcome of PAD
Analyse the sequential changes of albuminuria and the outcome of PAD
Measured: 12,24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Dec 2016
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ng Soh Ching, MD, Principal investigator, Chang Gung Memorial Hospital, Keelung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378024
- Sponsor's protocol ID
- CMRPG2F0181
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Correlation of Near Infrared Spectroscopy, ABI, Exercise Test, baPWV and Microalbuminuria With Peripheral Artery Occlusion Disease and Other Atherosclerosis Outcome
- ClinicalTrials.gov ID
- NCT03378024
- Acronym / sponsor ID
- CMRPG2F0181
- Conditions
- Diabetes, Peripheral Arterial Occlusive Disease
- Keywords
- Oscillometric device, repetitive Active Pedal Plantarflexion (APP) exercise test, brachial-ankle pulse wave velocity (baPWV)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 19 Dec 2017 (actual)
- 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.
By utilizing Near infrared spectroscopy (NIRS), the local blood flow, tissue oxygenation (StO2), and recovery time of ischemic leg; can be determined. It is reasonable to standardize an easy, simple and safe Active Pedal Plantarflexion (APP) exercise test working load which can achieve the lowest StO2 and other parameters in ischemic leg through observation of NIRS. After standardized of an effective APP test, a determination of a new cutoff value of resting ABI in diagnosing PAD can probably be searched. Analysing the correlation of baPWV with ABI, atherosclerosis risk factors and parameters with atherosclerosis outcome. Observation the Sequential changes of baPWV, ABI and microalbuminuria after managing the atherosclerosis risks, and analyze their influence on the outcome of PAD, coronary artery disease(CAD) and cerebral vascular disease(CVA) outcomes.
Detailed description
Exercise testing by Active Pedal Plantar flexion:
The investigators plan to collect 140 cases:
- Healthy subjects with no apparent atherosclerotic risk [< 65 y/o, no diabetic mellitus (DM), no hypertension, or no hyperlipidemia, not obese, not current smoker, no smoking history >10 years] 4(n=5)
- Patients at risks (e.g. hypertension, hyperlipidemia) (n=5) but without DM,
- Type 1 and Type 2 DM patients with normal ABI( >1.0)and normal Toe-brachial index (TBI) (> 0.6) without intermittent claudication(by Edinburgh claudication questionnaire), nor PAD diagnosis (n= 10)
- DM normal ABI>1.0 and normal TBI (> 0.6) with suspected symptoms (intermittent claudication, non healing ulcer) (n=10),
- DM normal or borderline ABI( >1, 0.91~0.99) but low TBI (< 0.6), or with suspected symptoms (intermittent claudication, non healing ulcer) (n=20),
- DM patients with borderline ABI (0.91-0.99) (n=50) with or without leg symptoms,
- DM patients abnormal Low ABI (<0.9) (n=30) with or without leg symptoms,
- DM patients abnormal high ABI (> 1.3) (n=10)with or without leg symptoms, Post-exercise ABI with APP, and NIRS examination during APP exercise test will be performed.
The investigators also plan to collect 500 cases of nonpregnant, ≥ 40 years old DM patients, obtained baPWV and the resting ABI by oscillometric device (Omron colin, Japan). The investigators will apply this novel technique to assess the extent of arteriosclerosis and atherosclerosis by oscillometric device in our DM patient without PAD (ABI >0.9).
Collect baseline characteristics and follow up annual data: Age, sex, body weight, height, BMI, waist circumferences, history of smoking (ex-smoker, current), coexisting hypertension, hyperlipidemia, DM duration, presence of chronic DM complications of neuropathy, retinopathy (by fundus camera), nephropathy (cr, estimate glomerular filtration rate(eGFR), proteinuria, microalbuminuria). The biochemistry data involving atherosclerotic risk including: systolic blood pressure, diastolic pressure, mean pulse pressure, HbA1c, total cholesterol, LDL-Cholesterol(LDL-C), HDL-Cholesterol(HDL-C), triglyceride, creatinine, microalbuminuria,, high sensitive C-Reactive Protein (hs CRP), baseline EKG all will be collected. All the above data will be followed up annually for 3 years to analyze the correlation of progressive change of baPWV, ABI and microalbuminuria with the atherosclerosis event and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic mellitus patients | – | Device: oscillometric (Omron Colin co)Measure the brachial-ankle pulse wave velocity (baPWV) and the resting ankle-brachial index(ABI) of pre-exercise and post-exercise by the oscillometric (Omron Colin co.). And follow up for 3 years to identify of the correlation with PAD outcome. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nonpregnant \& ≥ 20 years old type1 and type 2 diabetic patients
Key inclusion criteria (2 listed)
- type 1 diabetic patients
- type 2 diabetic patients
Key exclusion criteria (13 listed)
- Pregnancy
- Critical limb ischemia (gangrene change)
- A permanent pacemaker implant
- Systolic BP ≥ 200 mmHg or diastolic BP ≥100 mmHg
- Symptomatic orthostatic blood pressure drop ≥ 20 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oscillometric (Omron Colin co)fast measurements of the brachial-ankle pulse wave velocity (baPWV) and the resting ankle-brachial index(ABI) with the oscillometric method (Omron Colin co, Japan) | Device | diabetic mellitus patients |
Primary outcome
Define the correlation between NIRS and ABI
Time frame: 12 month
Analyse the correlation of NIRS with different ABI
Defined APP exercise ABI criteria for PAD diagnosis
Time frame: 12 month
Design APP exercise with effective working load to defined ABI criteria for PAD diagnosis
The correlation of changes of baPWV and the outcome of PAD
Time frame: 12,24 and 36 months
Analyse the sequential changes of baPWV and the outcome of PAD
The correlation of changes of exercise ABI and the outcome of PAD
Time frame: 12,24 and 36 months
Analyse the sequential changes of exercise ABI and the outcome of PAD
The correlation of changes of albuminuria and the outcome of PAD
Time frame: 12,24 and 36 months
Analyse the sequential changes of albuminuria and the outcome of PAD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Ng Soh Ching, MD principal investigator
Chang Gung Memorial Hospital, Keelung
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Peripheral Arterial Occlusive Disease, run by Chang Gung Memorial Hospital.
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 2 inclusion and 13 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Define the correlation between NIRS and ABI (time frame: 12 month). The study lists 5 primary outcomes in all. 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 19 Dec 2017.