Neuropathy, Diabetic, Neuropathy, Painful
Conditions
Keywords
diabetes, neuropathy, early detection, small nerve fibers
Brief summary
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.
Interventions
DIAGNOSTIC_TESTPerception Threshold Tracking (PTT)
low-current electrical stimulation of both large- and small nerve fibers.
DIAGNOSTIC_TESTAxon-flair mediated respons
Laser-doppler examination of small blood vessels in the peripheral skin.
DIAGNOSTIC_TESTHeart rate variability
4 measurements of heart rate.
DIAGNOSTIC_TESTQuantitative Sensory Testing (QST)
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.
DIAGNOSTIC_TESTPeripheral blood pressure and transcutaneous oxygen tension
Ankle/brachial index, toe/brachial index, TcpO2.
DIAGNOSTIC_TESTMagnetic Resonance Imaging (MRI)
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
DIAGNOSTIC_TESTQuestionnaires
Questionnaires for detecting painful neuropathy
DIAGNOSTIC_TESTCorneal Confocal Microscopy /CCM)
Confocal microscopy of the cornea measuring NBD, NFD, NFL
Sponsors
Aalborg University
Aalborg University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women minimum 18 years of age and maximum 75 years of age 2. Signed informed consent form 3. Diagnosed with diabetes type I (for group 1-3) 4. Diagnosed with DPN defined as a threshold above 25-volt biothesiometry or absent feeling on the big toe using 10g-monofilament. (for group 1-2) 5. Answered questionnaire: PainDETECT 6. Nothing abnormal on initial tests (group 4) 7. Accepted initial screening blood samples 8. MRI-compatible participant
Exclusion criteria
* 1\. Current or previous alcohol- or drug abuse 2. Abnormal screening blood samples 3. Not being able to understand Danish written and/or verbally 4. Not being able to corporate to examination (e.g. not being able to speak, suffering from senile dementia etc.) 5. Previous chemotherapy or intake of experimental medicine 6. Active HSV- or VZV-infection or known HIV 7. Known severe skin disease 8. Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.) 9. Critical limb ischemia defined as in current clinical consensus 10. Allergy or intolerance to histamine or inability to make do without for one day 11. Pregnancy 12. Active cancer-disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic value of CCM, PTT, AF and MRI | End of study (when all patients have completed all sessions. Latest 31. december 2021) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of PainDETECT in diabetes | End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021) | Correlation between PainDETECT and DN4 will be reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory measures | End of study (latest december 31 2021). | An multi-variant analysis to determine the predictive ability of combinations of primary outcome measures. |
Countries
Denmark
Outcome results
None listed