Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Neuropathy, DiabeticSmall Nerve Fiber NeuropathyType 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

Trial Locations (1)

9000

RECRUITING

Aalborg University Hospital, Aalborg

All Listed Sponsors
collaborator

Aalborg University

OTHER

collaborator

University of Aarhus

OTHER

lead

Aalborg University Hospital

OTHER