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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.
Exercise testing by Active Pedal Plantar flexion:
The investigators plan to collect 140 cases:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Define the correlation between NIRS and ABI | Analyse the correlation of NIRS with different ABI | 12 month |
| Defined APP exercise ABI criteria for PAD diagnosis | Design APP exercise with effective working load to defined ABI criteria for PAD diagnosis | 12 month |
| The correlation of changes of baPWV and the outcome of PAD | Analyse the sequential changes of baPWV and the outcome of PAD | 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 | 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 | 12,24 and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Nonpregnant & ≥ 20 years old type1 and type 2 diabetic patients
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| Name | Affiliation | Role |
|---|---|---|
| Ng Soh Ching, MD | Chang Gung Memorial Hospital, Keelung | Principal Investigator |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| C564658 | Peripheral Arterial Occlusive Disease 1 |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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