Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)
MEDON
Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedNovember 2, 2021
November 1, 2021
2.1 years
August 28, 2019
November 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
End of study (when all patients have completed all sessions. Latest 31. december 2021)
Secondary Outcomes (1)
Validation of PainDETECT in diabetes
End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)
Other Outcomes (1)
Exploratory measures
End of study (latest december 31 2021).
Study Arms (4)
Type 1 diabetes and painful neuropathy
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Interventions
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.
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aalborg University Hospitallead
- Aalborg Universitycollaborator
Study Sites (1)
Aalborg University Hospital
Aalborg, North Denmark, 9000, Denmark
Related Publications (3)
Moussa F, Taleb S, Borbjerg MK, Croosu SS, Morch CD, Frokjaer JB, Hansen TM, Ejskjaer N, Roikjer J. Corneal Immune Cells and Their Relation to Diabetic Peripheral Neuropathy and Neuropathic Pain. Muscle Nerve. 2026 Jan;73(1):72-78. doi: 10.1002/mus.70061. Epub 2025 Nov 17.
PMID: 41246983DERIVEDRoikjer J, Croosu SS, Sejergaard BF, Hansen TM, Frokjaer JB, Sondergaard CB, Petropoulos IN, Malik RA, Nielsen E, Morch CD, Ejskjaer N. Diagnostic Accuracy of Perception Threshold Tracking in the Detection of Small Fiber Damage in Type 1 Diabetes. J Diabetes Sci Technol. 2024 Sep;18(5):1157-1164. doi: 10.1177/19322968231157431. Epub 2023 Feb 24.
PMID: 36825610DERIVEDRoikjer 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.
PMID: 36130086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niels Ejskjær, Professor
Steno Diabtes Center North Denmark, Aalborg University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Endocrinology
Study Record Dates
First Submitted
August 28, 2019
First Posted
September 6, 2019
Study Start
August 12, 2019
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
November 2, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- During and after the study. Data will be available no longer than needed for analyzing.
- Access Criteria
- anonymized data
Data will be shared with collaborating department: Department of Radiology with the purpose of analyzing the data and comparing it to their MRI scans. Data will be shared with Aalborg University with the purpose of analyzing data.