Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy

Summary

Predicting early onset neuropathy in people with type 1 diabetes

Conditions

• Neuropathy, Diabetic
• Small Nerve Fiber Neuropathy
• Type 1 Diabetes

Interventions

DIAGNOSTIC_TEST

Skin biopsies with quantification of intra-epidermal nerve fibre density

Skin biopsy

DIAGNOSTIC_TEST

Perception Threshold Tracking

Transcutaneous stimulation of large and small nerve fibres using weak electrical currents

DIAGNOSTIC_TEST

Thermal perception thresholds

Heat and cold perception thresholds

DIAGNOSTIC_TEST

Corneal confocal Microscopy

Corneal nerve fibre density, corneal nerve fibre length, corneal nerve branch density

DIAGNOSTIC_TEST

MRI

Functional and structural MRI pictures of peripheral nerves and CNS

DIAGNOSTIC_TEST

Nerve conduction studies

Nerve conduction and amplitude of Sural nerve

OTHER

Composite scores and questionnaires

Composite scores and questionnaires

Sponsors & Collaborators

• Aalborg University

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Aalborg University Hospital

  lead OTHER

Principal Investigators

• Peter Vestergaard, PhD · Steno Diabetes Center North Denmark

• Johan M Røikjer, PhD · Steno Diabetes Center North Denmark

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Denmark

Study Locations