MEDON aims to examine new methods for early detection and grading of diabetic peripheral neuropathy focusing on both small- and large nerve fibers. Furthermore, MEDON aims to describe differences between people with classic diabetic peripheral neuropathy and those with painful diabetic neuropathy.
Study Type
OBSERVATIONAL
Enrollment
80
low-current electrical stimulation of both large- and small nerve fibers.
Laser-doppler examination of small blood vessels in the peripheral skin.
4 measurements of heart rate.
Aalborg University Hospital
Aalborg, North Denmark, Denmark
Diagnostic value of CCM, PTT, AF and MRI
Using Quantitative Sensory Testing (small fibers) and conventional nerve conduction studies (large fibers) as golden standards, we will determine the prognostic value of: Perception Threshold Tracking Corneal Confocal Microscopy Axon-flair mediated response MRI-scans in detecting neuropathy. Sensitivity and specificity will be reported. OBS! Tests will be tested in the initial groups and AFTER a group re-arrangement based on results from QST and NCS.
Time frame: End of study (when all patients have completed all sessions. Latest 31. december 2021)
Validation of PainDETECT in diabetes
Correlation between PainDETECT and DN4 will be reported.
Time frame: End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)
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Seven tests measuring 13 parameters including heat- and cold-detection and pain thresholds, mechanical pain treshold, mechanical detection threshold, pressure pain treshold and vibration threshold.
Ankle/brachial index, toe/brachial index, TcpO2.
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
Questionnaires for detecting painful neuropathy
Confocal microscopy of the cornea measuring NBD, NFD, NFL