Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)
NCT ID: NCT04078516
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2019-08-12
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Type 1 diabetes and painful neuropathy
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Perception Threshold Tracking (PTT)
low-current electrical stimulation of both large- and small nerve fibers.
Axon-flair mediated respons
Laser-doppler examination of small blood vessels in the peripheral skin.
Heart rate variability
4 measurements of heart rate.
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.
Peripheral blood pressure and transcutaneous oxygen tension
Ankle/brachial index, toe/brachial index, TcpO2.
Magnetic Resonance Imaging (MRI)
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
Questionnaires
Questionnaires for detecting painful neuropathy
Corneal Confocal Microscopy /CCM)
Confocal microscopy of the cornea measuring NBD, NFD, NFL
Type 1 diabetes and non-painful neuropathy
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Perception Threshold Tracking (PTT)
low-current electrical stimulation of both large- and small nerve fibers.
Axon-flair mediated respons
Laser-doppler examination of small blood vessels in the peripheral skin.
Heart rate variability
4 measurements of heart rate.
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.
Peripheral blood pressure and transcutaneous oxygen tension
Ankle/brachial index, toe/brachial index, TcpO2.
Magnetic Resonance Imaging (MRI)
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
Questionnaires
Questionnaires for detecting painful neuropathy
Corneal Confocal Microscopy /CCM)
Confocal microscopy of the cornea measuring NBD, NFD, NFL
Type 1 diabetes and no neuropathy
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Perception Threshold Tracking (PTT)
low-current electrical stimulation of both large- and small nerve fibers.
Axon-flair mediated respons
Laser-doppler examination of small blood vessels in the peripheral skin.
Heart rate variability
4 measurements of heart rate.
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.
Peripheral blood pressure and transcutaneous oxygen tension
Ankle/brachial index, toe/brachial index, TcpO2.
Magnetic Resonance Imaging (MRI)
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
Questionnaires
Questionnaires for detecting painful neuropathy
Corneal Confocal Microscopy /CCM)
Confocal microscopy of the cornea measuring NBD, NFD, NFL
Matched controls without diabetes
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Perception Threshold Tracking (PTT)
low-current electrical stimulation of both large- and small nerve fibers.
Axon-flair mediated respons
Laser-doppler examination of small blood vessels in the peripheral skin.
Heart rate variability
4 measurements of heart rate.
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.
Peripheral blood pressure and transcutaneous oxygen tension
Ankle/brachial index, toe/brachial index, TcpO2.
Magnetic Resonance Imaging (MRI)
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
Questionnaires
Questionnaires for detecting painful neuropathy
Corneal Confocal Microscopy /CCM)
Confocal microscopy of the cornea measuring NBD, NFD, NFL
Interventions
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Perception Threshold Tracking (PTT)
low-current electrical stimulation of both large- and small nerve fibers.
Axon-flair mediated respons
Laser-doppler examination of small blood vessels in the peripheral skin.
Heart rate variability
4 measurements of heart rate.
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.
Peripheral blood pressure and transcutaneous oxygen tension
Ankle/brachial index, toe/brachial index, TcpO2.
Magnetic Resonance Imaging (MRI)
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
Questionnaires
Questionnaires for detecting painful neuropathy
Corneal Confocal Microscopy /CCM)
Confocal microscopy of the cornea measuring NBD, NFD, NFL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
70 Years
ALL
Yes
Sponsors
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Aalborg University
OTHER
Aalborg University Hospital
OTHER
Responsible Party
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Niels Ejskjær
Professor of Endocrinology
Principal Investigators
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Niels Ejskjær, Professor
Role: PRINCIPAL_INVESTIGATOR
Steno Diabtes Center North Denmark, Aalborg University Hospital
Locations
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Aalborg University Hospital
Aalborg, North Denmark, Denmark
Countries
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References
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Roikjer 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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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N-20190003
Identifier Type: -
Identifier Source: org_study_id