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Recruiting NCT05546138

NCT05546138 Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy

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Clinical Trial Summary
NCT ID NCT05546138
Status Recruiting
Phase
Sponsor Aalborg University Hospital
Condition Neuropathy, Diabetic
Study Type OBSERVATIONAL
Enrollment 200 participants
Start Date 2023-10-01
Primary Completion 2029-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 60 Years
Study Type OBSERVATIONAL
Interventions
Skin biopsies with quantification of intra-epidermal nerve fibre densityPerception Threshold TrackingThermal perception thresholds

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 200 participants in total. It began in 2023-10-01 with a primary completion date of 2029-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Predicting early onset neuropathy in people with type 1 diabetes

Eligibility Criteria

Inclusion Criteria: * Men and women aged 18-80 years * Diagnosed with diabetes (of any type) * No clinically established diabetic peripheral neuropathy at inclusion Exclusion Criteria: * 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 * Planned or likely discontinuation of care at Aalborg University Hospital * Known hematologic disorders resulting in a markedly reduced ability to stop small bleedings * Severe limb ischemia * Active diabetic foot ulcers * Previous amputations * Severe skin diseases or diseases known to cause neural damage * Pregnancy at inclusion

Contact & Investigator

Central Contact

Johan M Røikjer, PhD

✉ j.roeikjaer@rn.dk

📞 +45 97663651

Principal Investigator

Peter Vestergaard, PhD

STUDY CHAIR

Steno Diabetes Center North Denmark

Frequently Asked Questions

Who can join the NCT05546138 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Neuropathy, Diabetic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05546138 currently recruiting?

Yes, NCT05546138 is actively recruiting participants. Contact the research team at j.roeikjaer@rn.dk for enrollment information.

Where is the NCT05546138 trial being conducted?

This trial is being conducted at Aalborg, Denmark.

Who is sponsoring the NCT05546138 clinical trial?

NCT05546138 is sponsored by Aalborg University Hospital. The principal investigator is Peter Vestergaard, PhD at Steno Diabetes Center North Denmark. The trial plans to enroll 200 participants.

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