Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy

ConditionsNeuropathy, Diabetic Small Nerve Fiber Neuropathy Type 1 Diabetes

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorAalborg University Hospital

About this trial

Predicting early onset neuropathy in people with type 1 diabetes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women aged 18-80 years

Diagnosed with diabetes (of any type)

No clinically established diabetic peripheral neuropathy at inclusion

Disqualifiers

Alcohol or drug abuse within the last year (prior to inclusion)

Chemotherapy (prior or within study period) or experimental medicine

Severe vitamin deficiencies

Inability to understand or comply with the examinations

Trial population

Type 1 diabetes without established neuropathy with planned continuity of care at Steno Diabetes Center North Denmark, Aalborg

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Skin biopsies with quantification of intra-epidermal nerve fibre density
Diagnostic test
Skin biopsy
Perception Threshold Tracking
Diagnostic test
Transcutaneous stimulation of large and small nerve fibres using weak electrical currents
Thermal perception thresholds
Diagnostic test
Heat and cold perception thresholds
Corneal confocal Microscopy
Diagnostic test
Corneal nerve fibre density, corneal nerve fibre length, corneal nerve branch density
MRI
Diagnostic test
Functional and structural MRI pictures of peripheral nerves and CNS
Nerve conduction studies
Diagnostic test
Nerve conduction and amplitude of Sural nerve
Composite scores and questionnaires
Other intervention
Composite scores and questionnaires

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Type 1 diabetes without known peripheral neuropathy7 interventions

Trial outcomes

Primary outcomes

Prediction of early onset neuropathy

Retrospective evaluation of the predictive power for each of the diagnostic tests

Time frame

1,3,5,7,9 years

Comparison of Perception Threshold Tracking (PTT) and skin biopsies

Sensitivity, specificity, PPV, NPV of PTT compared to skin biopsies

Time frame

1-2 years

Progression and regression of neuropathy

Description of the natural history of the development of neuropathy

Time frame

1-9 years

Secondary outcomes

Development and testing of single-use electrode for PTT

As title states

Time frame

5 years

Development and testing of new pulse shapes for PTT

As title states

Time frame

5 years

Correlation between central and peripheral measurements

MRI-scans vs peripheral measurements

Time frame

1-5 years

Other outcomes

Stability of skin biopsies over time

Repeated analysis of intra-epidermal nerve fibre density in skin biopsies frozen several years

Time frame

9 years

fMRI as a marker for progression of neuropathy

as title states

Time frame

9 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University Hospital

Lead sponsor

Aalborg University

Collaborator

University of Aarhus

Collaborator

Source ClinicalTrials.gov

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