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

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.

Conditions

• Neuropathy, Diabetic
• Neuropathy, Painful

Interventions

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Perception Threshold Tracking (PTT)

low-current electrical stimulation of both large- and small nerve fibers.

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Axon-flair mediated respons

Laser-doppler examination of small blood vessels in the peripheral skin.

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Heart rate variability

4 measurements of heart rate.

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Quantitative Sensory Testing (QST)

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.

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Peripheral blood pressure and transcutaneous oxygen tension

Ankle/brachial index, toe/brachial index, TcpO2.

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Magnetic Resonance Imaging (MRI)

MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.

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Questionnaires

Questionnaires for detecting painful neuropathy

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Corneal Confocal Microscopy /CCM)

Confocal microscopy of the cornea measuring NBD, NFD, NFL

Sponsors & Collaborators

• Aalborg University

  collaborator OTHER

• Aalborg University Hospital

  lead OTHER

Principal Investigators

• Niels Ejskjær, Professor · Steno Diabtes Center North Denmark, Aalborg University Hospital

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-12

Primary Completion

2021-08-31

Completion

2021-08-31

Countries

• Denmark

Study Locations