Clinical trial NCT04078516: Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)
Official title: Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathy, Diabetic
Neuropathy, Painful
Keywords: diabetes
neuropathy
early detection
small nerve fibers
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2019-09-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population include four well-defined groups of subjects:

1. Patients with Type 1 diabetes and painful diabetic peripheral neuropathy (DPN).
2. Patients with Type 1 diabetes and non-painful diabetic peripheral neuropathy (DPN)
3. Patients with Type 1 diabetes and without diabetic peripheral neuropathy (VPT\<15) (DPN).
4. Healthy control subjects matched for age, BMI, and gender. Diabetes duration, HbA1c, insulin use, ethnicity, and co-morbidities will be matched between group 1, 2 and 3 to best ability.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic value of CCM, PTT, AF and MRI
timeFrame: End of study (when all patients have completed all sessions. Latest 31. december 2021)
Secondary outcomes:
measure: Validation of PainDETECT in diabetes
timeFrame: End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)
Other outcomes:
measure: Exploratory measures
timeFrame: End of study (latest december 31 2021).
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North Denmark
Study officials:
affiliation: Steno Diabtes Center North Denmark, Aalborg University Hospital
name: Niels Ejskjær, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roikjer J, Croosu SS, Frokjaer JB, Hansen TM, Arendt-Nielsen L, Ejskjaer N, Morch CD. Perception threshold tracking: validating a novel method for assessing function of large and small sensory nerve fibers in diabetic peripheral neuropathy with and without pain. Pain. 2023 Apr 1;164(4):886-894. doi: 10.1097/j.pain.0000000000002780. Epub 2022 Sep 19.