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

Aalborg University Hospital

Status: Completed

Conditions: Neuropathy, Diabetic; Neuropathy, Painful

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

Study type: Observational

Funder types: Other

Identifiers

NCT04078516

N-20190003

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Type 1 diabetes and painful neuropathy

Description:

No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.

Treatment:

Diagnostic Test: Perception Threshold Tracking (PTT)

Diagnostic Test: Questionnaires

Diagnostic Test: Corneal Confocal Microscopy /CCM)

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Diagnostic Test: Quantitative Sensory Testing (QST)

Diagnostic Test: Heart rate variability

Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension

Diagnostic Test: Axon-flair mediated respons

Type 1 diabetes and non-painful neuropathy

Description:

No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.

Treatment:

Diagnostic Test: Perception Threshold Tracking (PTT)

Diagnostic Test: Questionnaires

Diagnostic Test: Corneal Confocal Microscopy /CCM)

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Diagnostic Test: Quantitative Sensory Testing (QST)

Diagnostic Test: Heart rate variability

Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension

Diagnostic Test: Axon-flair mediated respons

Type 1 diabetes and no neuropathy

Description:

No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.

Treatment:

Diagnostic Test: Perception Threshold Tracking (PTT)

Diagnostic Test: Questionnaires

Diagnostic Test: Corneal Confocal Microscopy /CCM)

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Diagnostic Test: Quantitative Sensory Testing (QST)

Diagnostic Test: Heart rate variability

Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension

Diagnostic Test: Axon-flair mediated respons

Matched controls without diabetes

Description:

No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.

Treatment:

Diagnostic Test: Perception Threshold Tracking (PTT)

Diagnostic Test: Questionnaires

Diagnostic Test: Corneal Confocal Microscopy /CCM)

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Diagnostic Test: Quantitative Sensory Testing (QST)

Diagnostic Test: Heart rate variability

Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension

Diagnostic Test: Axon-flair mediated respons