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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes | People with type 1 diabetes above 40 years |
| |
| People with type 2 diabetes | People with type 2 diabetes above 50 years |
| |
| Healthy controls | Healthy controls without diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantative Sensory Testing | Diagnostic Test | Evaluation of small fiber neuropathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-existence of peripheral- and vestiubular neuropathy in people with diabetes | Vestibular neuropathy (measured by pathological video head impulse test (v-Hit) (one-sided, two-sided or specific arcways)) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes. | through study completion, an average of 2 years |
| Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes | Dynamic balance (measured by Bertec) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes. | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy | QST / NC-Stat DPNCheck vs v-Hit | through study completion, an average of 2 years |
| Correlation between distal neuropathy and dynamic postural control (including patterns) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory | accelerometer (SENS Innovation, Copenhagen, Denmark) measures (postural control during walking) | through study completion, an average of 2 years |
| Exploratory | Correlations between different outcomes of Bertec and v-Hit vs peripheral neuropathy (all individual examinations and arcways) |
Inclusion Criteria:
Exclusion Criteria:
8. Not being able to understand Danish written and/or verbally 9. Terms according to investigators judgement that makes subjects unsuitable to participate including lack of understanding or reduced physical ability. 10. Participating in other clinical studies 11. Maximum of 10 hours of weekly exercise.
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People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37515636 | Derived | Mahalingasivam AA, Jespersen AK, Ejskjaer N, Hougaard DD, Vestergaard P, Rasmussen NH, Roikjer J. The co-existence of peripheral and vestibular neuropathy in diabetes: a cross-sectional study. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):663-672. doi: 10.1007/s00405-023-08130-6. Epub 2023 Jul 29. |
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Possible requirement for external data analysis
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| NCStat-DPN-Check | Diagnostic Test | Evaluation of large fiber neuropathy |
|
| Composite Autonomic Symptom Score 31 | Diagnostic Test | Evaluation of autonomic neuropathy |
|
| Computerized dynamic posturography | Diagnostic Test | Evaluation of dynamic postural control |
|
|
| Video Head Impulse Test | Diagnostic Test | Evaluation of vertigo and the vestibular organ |
|
|
| Accelerometer | Diagnostic Test | Evaluation of gait pattern |
|
|
| Handgrip strength | Diagnostic Test | Evaluation of muscle strength |
|
|
| Dual Energy X-ray Absorbtimetry scan | Diagnostic Test | Evaluation of body composition |
|
|
| Force Plate Platform | Diagnostic Test | Evaluation of balance while standing still |
|
|
QST / NC-Stat DPNCheck vs accelerometer / Bertec |
| through study completion, an average of 2 years |
| The impact of peripheral neuropathy on postural control (In quite stance) | QST / Correlation between muscle strength and peripheral neuropathy vs Force Plate | through study completion, an average of 2 years |
| through study completion, an average of 2 years |
| Muscle strength and peripheral neuropathy | Correlation between muscle strength and peripheral neuropathy (DEXA-scans, hand grup strength, QST, Correlation between muscle strength and peripheral neuropathy | through study completion, an average of 2 years |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D020338 | Vestibular Neuronitis |
| D018908 | Muscle Weakness |
| D055948 | Sarcopenia |
| D003929 | Diabetic Neuropathies |
| D000071075 | Small Fiber Neuropathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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