NCT05546138|Recruiting
Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy
NeuroPredict
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NeuroPredict
Sponsor study identifier
observational
200
1 country
1
Study Start
October 1, 2023
Actual (reported)Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Predicting early onset neuropathy in people with type 1 diabetes
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2022
Actual (reported)September 19, 2022
Actual (reported)October 1, 2023
Actual (reported)December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prediction of early onset neuropathy
Retrospective evaluation of the predictive power for each of the diagnostic tests
1,3,5,7,9 years
Comparison of Perception Threshold Tracking (PTT) and skin biopsies
Sensitivity, specificity, PPV, NPV of PTT compared to skin biopsies
1-2 years
Progression and regression of neuropathy
Description of the natural history of the development of neuropathy
1-9 years
Development and testing of single-use electrode for PTT
5 years
Development and testing of new pulse shapes for PTT
5 years
Correlation between central and peripheral measurements
1-5 years
Stability of skin biopsies over time
9 years
fMRI as a marker for progression of neuropathy
9 years
People with type 1 diabetes without known peripheral neuropathy with "limited" diabetes duration
Skin biopsy
Transcutaneous stimulation of large and small nerve fibres using weak electrical currents
Type 1 diabetes without established neuropathy with planned continuity of care at Steno Diabetes Center North Denmark, Aalborg
Aalborg University Hospital
Aalborg, 9000, Denmark
Blood samples, skin biopsies
Peter Vestergaard, PhD
Steno Diabetes Center North Denmark
Johan M Røikjer, PhD
Steno Diabetes Center North Denmark
First Submitted
September 15, 2022
First Posted
September 19, 2022
Study Start
October 1, 2023
Actual (reported)Primary Completion
December 31, 2029
EstimatedDeep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy
Heat and cold perception thresholds
Corneal nerve fibre density, corneal nerve fibre length, corneal nerve branch density
Functional and structural MRI pictures of peripheral nerves and CNS
Nerve conduction and amplitude of Sural nerve
Composite scores and questionnaires
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 28, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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