Characterization and Prediction of Early Onset Diabetic Peripheral Neuropathy

NCT05546138 | Recruiting

• 1 other identifier: N-20220013
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Predicting early onset neuropathy in people with type 1 diabetes

Conditions

Neuropathy, Diabetic; Small Nerve Fiber Neuropathy; Type 1 Diabetes

Keywords

Diabetic neuropathy, Early detection, Clinical Endpoints, Prediction, Risk stratification

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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

Other Outcomes (2)

• Stability of skin biopsies over time

  9 years

• fMRI as a marker for progression of neuropathy

  9 years

Study Arms (1)

Type 1 diabetes without known peripheral neuropathy

People with type 1 diabetes without known peripheral neuropathy with "limited" diabetes duration

Diagnostic Test: Skin biopsies with quantification of intra-epidermal nerve fibre density; Diagnostic Test: Perception Threshold Tracking; Diagnostic Test: Thermal perception thresholds; Diagnostic Test: Corneal confocal Microscopy; Diagnostic Test: MRI; Diagnostic Test: Nerve conduction studies; Other: Composite scores and questionnaires

Interventions

Skin biopsies with quantification of intra-epidermal nerve fibre density DIAGNOSTIC_TEST

Skin biopsy

Also known as: PGP9.5, antibodies for subsets of ion-channels ect

Type 1 diabetes without known peripheral neuropathy

Perception Threshold Tracking DIAGNOSTIC_TEST

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

Also known as: PTT

Type 1 diabetes without known peripheral neuropathy

Thermal perception thresholds DIAGNOSTIC_TEST

Heat and cold perception thresholds

Also known as: Quantitative Sensory Testing

Type 1 diabetes without known peripheral neuropathy

Corneal confocal Microscopy DIAGNOSTIC_TEST

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

Also known as: CCM

Type 1 diabetes without known peripheral neuropathy

MRI DIAGNOSTIC_TEST

Functional and structural MRI pictures of peripheral nerves and CNS

Also known as: fMRI, DTI, neurography

Type 1 diabetes without known peripheral neuropathy

Nerve conduction studies DIAGNOSTIC_TEST

Nerve conduction and amplitude of Sural nerve

Also known as: NC-STAT DPNCheck

Type 1 diabetes without known peripheral neuropathy

Composite scores and questionnaires OTHER

Composite scores and questionnaires

Also known as: DN4, MNSI, NDS, NAFF

Type 1 diabetes without known peripheral neuropathy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Type 1 diabetes without established neuropathy with planned continuity of care at Steno Diabetes Center North Denmark, Aalborg

You may qualify if:

• Men and women aged 18-80 years
• Diagnosed with diabetes (of any type)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Links

• Steno Diabetes Center North Denmark

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, skin biopsies

MeSH Terms

Conditions

Diabetic Neuropathies; Small Fiber Neuropathy; Diabetes Mellitus, Type 1

Interventions

Magnetic Resonance Imaging; Diffusion Tensor Imaging; Nerve Conduction Studies; Surveys and Questionnaires; diazonaphthalenedisulfonic acid

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Neuroimaging; Diffusion Magnetic Resonance Imaging; Diagnostic Techniques, Neurological; Investigative Techniques; Electrodiagnosis; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Peter Vestergaard, PhD

  Steno Diabetes Center North Denmark

  STUDY CHAIR

• Johan M Røikjer, PhD

  Steno Diabetes Center North Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan M Røikjer, PhD

CONTACT

+45 97663651; j.roeikjaer@rn.dk

Niels Ejskjaer, PhD

CONTACT

+45 +4597663656; n.ejskjaer@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)