Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuropathy, Diabetic
- Sponsor
- Aalborg University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Diagnostic value of CCM, PTT, AF and MRI
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Niels Ejskjær
Professor of Endocrinology
Aalborg University Hospital
Eligibility Criteria
Inclusion Criteria
- •Men and women minimum 18 years of age and maximum 75 years of age
- •Signed informed consent form
- •Diagnosed with diabetes type I (for group 1-3)
- •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)
- •Answered questionnaire: PainDETECT
- •Nothing abnormal on initial tests (group 4)
- •Accepted initial screening blood samples
- •MRI-compatible participant
Exclusion Criteria
- •Current or previous alcohol- or drug abuse
- •Abnormal screening blood samples
- •Not being able to understand Danish written and/or verbally
- •Not being able to corporate to examination (e.g. not being able to speak, suffering from senile dementia etc.)
- •Previous chemotherapy or intake of experimental medicine
- •Active HSV- or VZV-infection or known HIV
- •Known severe skin disease
- •Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.)
- •Critical limb ischemia defined as in current clinical consensus
- •Allergy or intolerance to histamine or inability to make do without for one day
Outcomes
Primary Outcomes
Diagnostic value of CCM, PTT, AF and MRI
Time Frame: 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 Outcomes
- Validation of PainDETECT in diabetes(End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021))