RecruitingNCT05546138

Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy

Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy (NeuroPredict)


Sponsor

Aalborg University Hospital

Enrollment

200 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Predicting early onset neuropathy in people with type 1 diabetes


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study aims to better understand and predict early-stage nerve damage in the feet and legs caused by diabetes — a condition called diabetic peripheral neuropathy. Researchers want to catch it earlier before symptoms develop. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with diabetes (any type) - You do not yet have established diabetic nerve damage (neuropathy) at the time of enrollment **You may NOT be eligible if...** - You have had a serious problem with alcohol or drugs in the past year - You have had or are receiving chemotherapy or experimental treatments - You have severe vitamin deficiencies - You are pregnant - You have active foot ulcers, previous amputations, or severe limb blood flow problems - You have a blood disorder that makes it hard for small wounds to stop bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSkin biopsies with quantification of intra-epidermal nerve fibre density

Skin biopsy

DIAGNOSTIC_TESTPerception Threshold Tracking

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

DIAGNOSTIC_TESTThermal perception thresholds

Heat and cold perception thresholds

DIAGNOSTIC_TESTCorneal confocal Microscopy

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

DIAGNOSTIC_TESTMRI

Functional and structural MRI pictures of peripheral nerves and CNS

DIAGNOSTIC_TESTNerve conduction studies

Nerve conduction and amplitude of Sural nerve

OTHERComposite scores and questionnaires

Composite scores and questionnaires


Locations(1)

Aalborg University Hospital

Aalborg, Denmark

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NCT05546138


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