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

Sponsor
Aalborg University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04078516
Collaborator
Aalborg University (Other)
80
Enrollment
1
Location
24.6
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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)

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
Actual Study Start Date :
Aug 12, 2019
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Type 1 diabetes and painful neuropathy

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

Diagnostic Test: Perception Threshold Tracking (PTT)
low-current electrical stimulation of both large- and small nerve fibers.

Diagnostic Test: Axon-flair mediated respons
Laser-doppler examination of small blood vessels in the peripheral skin.
Other Names:
  • Laser-doppler

    • Diagnostic Test: Heart rate variability
    4 measurements of heart rate.
    Other Names:
  • Vagus TM

    • Diagnostic Test: 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.
    Other Names:
  • German Research Network on Neuropathic Pain (DFNS) standard protocol

    • Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension
    Ankle/brachial index, toe/brachial index, TcpO2.
    Other Names:
  • Perimed 6000

    • Diagnostic Test: Magnetic Resonance Imaging (MRI)
    MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.

    Diagnostic Test: Questionnaires
    Questionnaires for detecting painful neuropathy
    Other Names:
  • PainDETECT, Douleur Neuropathique 4

    • Diagnostic Test: 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.

    Diagnostic Test: Perception Threshold Tracking (PTT)
    low-current electrical stimulation of both large- and small nerve fibers.

    Diagnostic Test: Axon-flair mediated respons
    Laser-doppler examination of small blood vessels in the peripheral skin.
    Other Names:
  • Laser-doppler

    • Diagnostic Test: Heart rate variability
    4 measurements of heart rate.
    Other Names:
  • Vagus TM

    • Diagnostic Test: 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.
    Other Names:
  • German Research Network on Neuropathic Pain (DFNS) standard protocol

    • Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension
    Ankle/brachial index, toe/brachial index, TcpO2.
    Other Names:
  • Perimed 6000

    • Diagnostic Test: Magnetic Resonance Imaging (MRI)
    MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.

    Diagnostic Test: Questionnaires
    Questionnaires for detecting painful neuropathy
    Other Names:
  • PainDETECT, Douleur Neuropathique 4

    • Diagnostic Test: 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.

    Diagnostic Test: Perception Threshold Tracking (PTT)
    low-current electrical stimulation of both large- and small nerve fibers.

    Diagnostic Test: Axon-flair mediated respons
    Laser-doppler examination of small blood vessels in the peripheral skin.
    Other Names:
  • Laser-doppler

    • Diagnostic Test: Heart rate variability
    4 measurements of heart rate.
    Other Names:
  • Vagus TM

    • Diagnostic Test: 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.
    Other Names:
  • German Research Network on Neuropathic Pain (DFNS) standard protocol

    • Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension
    Ankle/brachial index, toe/brachial index, TcpO2.
    Other Names:
  • Perimed 6000

    • Diagnostic Test: Magnetic Resonance Imaging (MRI)
    MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.

    Diagnostic Test: Questionnaires
    Questionnaires for detecting painful neuropathy
    Other Names:
  • PainDETECT, Douleur Neuropathique 4

    • Diagnostic Test: 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.

    Diagnostic Test: Perception Threshold Tracking (PTT)
    low-current electrical stimulation of both large- and small nerve fibers.

    Diagnostic Test: Axon-flair mediated respons
    Laser-doppler examination of small blood vessels in the peripheral skin.
    Other Names:
  • Laser-doppler

    • Diagnostic Test: Heart rate variability
    4 measurements of heart rate.
    Other Names:
  • Vagus TM

    • Diagnostic Test: 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.
    Other Names:
  • German Research Network on Neuropathic Pain (DFNS) standard protocol

    • Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension
    Ankle/brachial index, toe/brachial index, TcpO2.
    Other Names:
  • Perimed 6000

    • Diagnostic Test: Magnetic Resonance Imaging (MRI)
    MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.

    Diagnostic Test: Questionnaires
    Questionnaires for detecting painful neuropathy
    Other Names:
  • PainDETECT, Douleur Neuropathique 4

    • Diagnostic Test: Corneal Confocal Microscopy /CCM)
    Confocal microscopy of the cornea measuring NBD, NFD, NFL

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Other Outcome Measures

    1. Exploratory measures [End of study (latest december 31 2021).]

      An multi-variant analysis to determine the predictive ability of combinations of primary outcome measures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aalborg University Hospital Aalborg North Denmark Denmark 9000

    Sponsors and Collaborators

    • Aalborg University Hospital
    • Aalborg University

    Investigators

    • Principal Investigator: Niels Ejskjær, Professor, Steno Diabtes Center North Denmark, Aalborg University Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Niels Ejskjær, Professor of Endocrinology, Aalborg University Hospital
    ClinicalTrials.gov Identifier:
    NCT04078516
    Other Study ID Numbers:
    • N-20190003
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Niels Ejskjær, Professor of Endocrinology, Aalborg University Hospital
    diabetes
    neuropathy
    early detection
    small nerve fibers
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases
    Diabetic Neuropathies

    Study Results

    No Results Posted as of Nov 2, 2021