Predicting early onset diabetic neuropathy in type 1 diabetes
Official title: Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy (NeuroPredict)
Run by Aalborg University Hospital · NCT05546138 · Data updated 2026-11-12
This study is trying to find early signs of nerve damage in people with type 1 diabetes to help catch problems before they get serious.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Aalborg) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | June 28, 2024 |
| Trial ID | NCT05546138 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are men and women aged 18-80 years diagnosed with diabetes but without clinically established diabetic peripheral neuropathy.
✕Probably not a fit
Patients with active diabetic foot ulcers, severe limb ischemia, or those who have previously undergone amputations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to predict the early onset of diabetic peripheral neuropathy in individuals with type 1 diabetes. It will utilize various methodologies, including skin biopsies to measure intra-epidermal nerve fiber density, perception threshold tracking, thermal perception thresholds, corneal confocal microscopy, and MRI. The goal is to identify reliable markers for early detection and risk stratification of neuropathy, which is often asymptomatic in its initial stages. By improving screening methods, the study seeks to enhance patient outcomes and prevent severe complications associated with diabetic neuropathy.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and intervention for diabetic neuropathy, potentially preventing severe complications such as foot ulcers and amputations.
How similar studies have gone: While diabetic neuropathy is a well-known complication of diabetes, this study's approach to early detection and risk stratification is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Aalborg University Hospital
Aalborg, Denmark Recruiting
Study contacts
- Principal investigator: Johan M Røikjer, PhD — Steno Diabetes Center North Denmark
- Study coordinator: Johan M Røikjer, PhD
- Email: j.roeikjaer@rn.dk
- Phone: +45 97663651
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.