Diabetes, Falls, and Fractures

Study Overview
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Brief Summary
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Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements

Official Title
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Diabetes, Falls, and Fractures

Conditions
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Diabetic Peripheral Neuropathy, Diabetes, Balance; Distorted, Vestibular Neuropathy, Muscle Weakness, Sarcopenia, Autonomic Neuropathy, Diabetic, Small Fiber Neuropathy

Intervention / Treatment
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* Diagnostic Test: Quantative Sensory Testing
* Diagnostic Test: NCStat-DPN-Check
* Diagnostic Test: Composite Autonomic Symptom Score 31
* Diagnostic Test: Computerized dynamic posturography
* Diagnostic Test: Video Head Impulse Test
* Diagnostic Test: Accelerometer
* Diagnostic Test: Handgrip strength
* Diagnostic Test: Dual Energy X-ray Absorbtimetry scan
* Diagnostic Test: Force Plate Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with minimum 40 years of age and maximum 70 years of age. Diagnosis of T1D or T2D Diagnosis of diabetes with at least one year prior to inclusion of the study Signed the informed consent. Exclusion Criteria: Severe decreased liver function (Alanin amino-transaminase (ALAT)>250u/l, GammaGlutamyltransferase (GGT)>150u/l) Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15mmol/L/1,73m2 Pregnancy or breast feeding Active malignancy or terminal ill. Current or previous alcohol- or drug abuse 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetes<br>People with type 1 diabetes above 40 years | Diagnostic Test: Quantative Sensory Testing<br>* Evaluation of small fiber neuropathy<br>Diagnostic Test: NCStat-DPN-Check<br>* Evaluation of large fiber neuropathy<br>Diagnostic Test: Composite Autonomic Symptom Score 31<br>* Evaluation of autonomic neuropathy<br>Diagnostic Test: Computerized dynamic posturography<br>* Evaluation of dynamic postural control<br>* Other names: Bertec;Diagnostic Test: Video Head Impulse Test<br>* Evaluation of vertigo and the vestibular organ<br>* Other names: V-Hit;Diagnostic Test: Accelerometer<br>* Evaluation of gait pattern<br>* Other names: Sens Innovation, Copenhagen Denmark;Diagnostic Test: Handgrip strength<br>* Evaluation of muscle strength<br>* Other names: Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea;Diagnostic Test: Dual Energy X-ray Absorbtimetry scan<br>* Evaluation of body composition<br>* Other names: Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA);Diagnostic Test: Force Plate Platform<br>* Evaluation of balance while standing still<br>* Other names: Plux Biosignals, S.A, Arruda dos Vinhos, Portugal;|
| People with type 2 diabetes<br>People with type 2 diabetes above 50 years | Diagnostic Test: Quantative Sensory Testing<br>* Evaluation of small fiber neuropathy<br>Diagnostic Test: NCStat-DPN-Check<br>* Evaluation of large fiber neuropathy<br>Diagnostic Test: Composite Autonomic Symptom Score 31<br>* Evaluation of autonomic neuropathy<br>Diagnostic Test: Computerized dynamic posturography<br>* Evaluation of dynamic postural control<br>* Other names: Bertec;Diagnostic Test: Video Head Impulse Test<br>* Evaluation of vertigo and the vestibular organ<br>* Other names: V-Hit;Diagnostic Test: Accelerometer<br>* Evaluation of gait pattern<br>* Other names: Sens Innovation, Copenhagen Denmark;Diagnostic Test: Handgrip strength<br>* Evaluation of muscle strength<br>* Other names: Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea;Diagnostic Test: Dual Energy X-ray Absorbtimetry scan<br>* Evaluation of body composition<br>* Other names: Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA);Diagnostic Test: Force Plate Platform<br>* Evaluation of balance while standing still<br>* Other names: Plux Biosignals, S.A, Arruda dos Vinhos, Portugal;|
| Healthy controls<br>Healthy controls without diabetes | Diagnostic Test: Quantative Sensory Testing<br>* Evaluation of small fiber neuropathy<br>Diagnostic Test: NCStat-DPN-Check<br>* Evaluation of large fiber neuropathy<br>Diagnostic Test: Composite Autonomic Symptom Score 31<br>* Evaluation of autonomic neuropathy<br>Diagnostic Test: Computerized dynamic posturography<br>* Evaluation of dynamic postural control<br>* Other names: Bertec;Diagnostic Test: Video Head Impulse Test<br>* Evaluation of vertigo and the vestibular organ<br>* Other names: V-Hit;Diagnostic Test: Accelerometer<br>* Evaluation of gait pattern<br>* Other names: Sens Innovation, Copenhagen Denmark;Diagnostic Test: Handgrip strength<br>* Evaluation of muscle strength<br>* Other names: Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea;Diagnostic Test: Dual Energy X-ray Absorbtimetry scan<br>* Evaluation of body composition<br>* Other names: Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA);Diagnostic Test: Force Plate Platform<br>* Evaluation of balance while standing still<br>* Other names: Plux Biosignals, S.A, Arruda dos Vinhos, Portugal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Balance, Vestibular Neuropathy, Muscle Weakness, Sarcopenia, Autonomic Neuropathy, Small Fiber Neuropathy