Actively Recruiting
Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy (NeuroPredict)
Led by Aalborg University Hospital · Updated on 2024-06-28
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aalborg University Hospital
Lead Sponsor
A
Aalborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand and predict early onset diabetic peripheral neuropathy, a common complication affecting up to half of people with diabetes. The study focuses on people with type 1 diabetes, combining established and experimental methods to evaluate both the structure and function of small nerve fibers. The goal is to improve early detection and screening methods for this condition, which currently lacks sensitive and reliable tests, and can lead to serious issues like foot ulcers, amputations, and pain. The study includes two observational cohorts: one with up to 1,000 people with diabetes and neuropathy at any stage, and a smaller group of 100-200 people with type 1 diabetes but no clinically detectable neuropathy. Participants will undergo various diagnostic tests such as skin biopsies, perception threshold tracking using electrical stimulation, thermal perception tests, corneal confocal microscopy, MRI scans, nerve conduction studies, and complete questionnaires. These assessments will help compare new screening methods to current standards. Participants will be followed long-term, with evaluations at multiple points up to nine years. They will continue their usual diabetes care and undergo enhanced screening during the study. Researchers will measure neuropathy progression, regression, and predict early onset using these advanced diagnostic tools. The study also includes development and testing of new equipment and techniques to improve nerve function measurement, with safety and adherence continuously monitored throughout the trial.
CONDITIONS
Brief Title
Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18-80 years
- Diagnosed with diabetes of any type
- No clinically established diabetic peripheral neuropathy at inclusion
You will not qualify if you...
- Alcohol or drug abuse within the last year
- Chemotherapy prior or during study or use of 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 causing reduced ability to stop small bleedings
- Severe limb ischemia
- Active diabetic foot ulcers
- Previous amputations
- Severe skin diseases or diseases known to cause nerve damage
- Pregnancy at inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing throughout the study
Participants undergo various assessments including skin biopsies, nerve conduction studies, MRI, corneal confocal microscopy, thermal perception thresholds, perception threshold tracking, and complete composite scores and questionnaires.
Annual visits for up to 9 years
Duration - Up to 9 years
Participants are followed annually to monitor progression or regression of diabetic peripheral neuropathy and to evaluate the predictive value of diagnostic methods.
Yearly visits
Trial Site Locations
Total: 1 location
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
Research Team
J
Johan M Røikjer, PhD
N
Niels Ejskjaer, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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