Diabetes peripheral neuropathy, diabetes microvascular disease, diabetes foot
Conditions
Interventions
diabetic group:7T MRI
healthy group:7T MRI
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diabetic patients; 1) 45-70 years old, male or female; 2) Diabetes diagnosed based on 2023 American Diabetes Association (ADA) criteria; 3) Diabetic lower limb lesions (any of the following): ? Toronto Clinical Scoring System (TCSS) = 6 points; ? nerve electrophysiology suggests that there are more than one nerve in the lower limb (common peroneal nerve, posterior tibial nerve and deep peroneal nerve) conduction velocity slowdown (= 2 standard deviations), which may be accompanied by a decrease in the amplitude of the wave; ? resting ABI = 0.90; ? ultrasound Doppler or CTA examination of the arteries of the lower limbs have stenosis or occlusive lesions; 4) Voluntarily sign an informed consent form. 2. Healthy controls; 1) 45-70 years old, male or female; 2) Exclusion of a diagnosis of diabetes based on the 2023 American Diabetes Association (ADA) criteria; 3) Voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Neuropathy due to other causes, such as cervical and lumbar spine lesions (nerve root compression and spinal stenosis, cervical and lumbar degenerative changes, etc.), cerebral infarction, and trauma; 2) Lower extremity vascular lesions due to other causes, such as polyarteritis, arteriovenous fistula, hereditary capillary dilatation, capillary malformations, etc; 3) Lower limb muscle lesions due to other causes, such as inflammatory myopathies, infectious myopathies, and amyotrophic lateral sclerosis; 4) Systolic blood pressure > 180 or diastolic blood pressure > 110 mmHg or fasting blood glucose > 14 mmol/L on the day of MRI; 5) Lower extremity edema from all types of causes; 6) Other contraindications to MRI such as cardiac stents, cochlear implants, aneurysm clips, metal implants, etc., are retained in the body; 7) AST/ALT >3 times the upper limit of normal; 8) Have had cholelithiasis, acute cholecystitis, or pancreatitis in the past 6 months; 9) Renal impairment (eGFR <30mL/minute/1.73m2); 10) Heart failure NYHA = class III; 11)12-lead ECG with clinically significant arrhythmia, current history of arrhythmia, second or third degree heart block, or left bundle branch block; 12) Myocardial infarction within the past 6 months; 13) History of TIA or stroke in the past 12 months; 14) Other objective disease progression, such as tumors and other diseases that are not suitable for participation in clinical trials; 15) Participation in other clinical trials within 30 days; 16) Women with recent (within 6 months) plans to have children, pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of lower extremity neuropathy (detected by ADC value on 7T MRI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of lower extremity vascular lesions (detected by, for example, peak congestion on 7T MRI BOLD sequences);Severity of lower extremity muscle lesions (detected by the maximum area of the flounder and gastrocnemius muscle cross-sections on 7T MRI imaging pictures);Toronto Clinical Scoring System (TCSS) Scores;Ankle Brachial Index, ABI;Toe Brachial Index, TBI;Cold sensation rating;Difference in AUC of 7T MRI technique compared to standard examination (nerve conduction velocity);sensitivity;specificity;Douleur Neuropathique 4 questions,DN4; | — |
Countries
China
Contacts
Public ContactLong Min
The First Affiliated Hospital of Army Medical University
Outcome results
None listed