Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)

Completed

• Conditions: Neuropathy, Diabetic; Neuropathy, Painful
• Interventions: Diagnostic Test: Perception Threshold Tracking (PTT); Diagnostic Test: Axon-flair mediated respons; Diagnostic Test: Heart rate variability; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension; Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Questionnaires; Diagnostic Test: Corneal Confocal Microscopy /CCM)

• Registration Number: NCT04078516
• Lead Sponsor: Aalborg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-12
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 diabetes and painful neuropathy	Magnetic Resonance Imaging (MRI)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Heart rate variability	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and painful neuropathy	Peripheral blood pressure and transcutaneous oxygen tension	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Axon-flair mediated respons	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Peripheral blood pressure and transcutaneous oxygen tension	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Questionnaires	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Axon-flair mediated respons	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Questionnaires	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and painful neuropathy	Perception Threshold Tracking (PTT)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and painful neuropathy	Heart rate variability	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and painful neuropathy	Questionnaires	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and painful neuropathy	Corneal Confocal Microscopy /CCM)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Perception Threshold Tracking (PTT)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Perception Threshold Tracking (PTT)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Quantitative Sensory Testing (QST)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Peripheral blood pressure and transcutaneous oxygen tension	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and painful neuropathy	Axon-flair mediated respons	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and painful neuropathy	Quantitative Sensory Testing (QST)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Heart rate variability	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Questionnaires	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Corneal Confocal Microscopy /CCM)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Perception Threshold Tracking (PTT)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Heart rate variability	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Quantitative Sensory Testing (QST)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Magnetic Resonance Imaging (MRI)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Corneal Confocal Microscopy /CCM)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Quantitative Sensory Testing (QST)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Magnetic Resonance Imaging (MRI)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and non-painful neuropathy	Corneal Confocal Microscopy /CCM)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Axon-flair mediated respons	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Type 1 diabetes and no neuropathy	Magnetic Resonance Imaging (MRI)	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Matched controls without diabetes	Peripheral blood pressure and transcutaneous oxygen tension	No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, North Denmark, Denmark