Diabetes, Falls, and Fractures
- Conditions
- Small Fiber NeuropathyDiabetic Peripheral NeuropathyVestibular NeuropathyAutonomic Neuropathy, DiabeticBalance; DistortedMuscle WeaknessSarcopeniaDiabetes
- Interventions
- Diagnostic Test: Quantative Sensory TestingDiagnostic Test: NCStat-DPN-CheckDiagnostic Test: Composite Autonomic Symptom Score 31Diagnostic Test: Computerized dynamic posturographyDiagnostic Test: Video Head Impulse TestDiagnostic Test: AccelerometerDiagnostic Test: Handgrip strengthDiagnostic Test: Dual Energy X-ray Absorbtimetry scanDiagnostic Test: Force Plate Platform
- Registration Number
- NCT05389566
- Lead Sponsor
- Aalborg University Hospital
- Brief Summary
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- 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.
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Severe decreased liver function (Alanin amino-transaminase (ALAT)>250u/l, GammaGlutamyltransferase (GGT)>150u/l)
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Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15mmol/L/1,73m2
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Pregnancy or breast feeding
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Active malignancy or terminal ill.
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Current or previous alcohol- or drug abuse
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Type 1 diabetes Accelerometer People with type 1 diabetes above 40 years Type 1 diabetes Handgrip strength People with type 1 diabetes above 40 years Type 1 diabetes Dual Energy X-ray Absorbtimetry scan People with type 1 diabetes above 40 years People with type 2 diabetes Quantative Sensory Testing People with type 2 diabetes above 50 years People with type 2 diabetes NCStat-DPN-Check People with type 2 diabetes above 50 years Healthy controls Composite Autonomic Symptom Score 31 Healthy controls without diabetes Healthy controls Video Head Impulse Test Healthy controls without diabetes Healthy controls Accelerometer Healthy controls without diabetes Healthy controls Handgrip strength Healthy controls without diabetes People with type 2 diabetes Computerized dynamic posturography People with type 2 diabetes above 50 years People with type 2 diabetes Video Head Impulse Test People with type 2 diabetes above 50 years Type 1 diabetes Computerized dynamic posturography People with type 1 diabetes above 40 years Type 1 diabetes Video Head Impulse Test People with type 1 diabetes above 40 years Type 1 diabetes Quantative Sensory Testing People with type 1 diabetes above 40 years Type 1 diabetes Composite Autonomic Symptom Score 31 People with type 1 diabetes above 40 years People with type 2 diabetes Composite Autonomic Symptom Score 31 People with type 2 diabetes above 50 years Type 1 diabetes NCStat-DPN-Check People with type 1 diabetes above 40 years Type 1 diabetes Force Plate Platform People with type 1 diabetes above 40 years People with type 2 diabetes Accelerometer People with type 2 diabetes above 50 years People with type 2 diabetes Dual Energy X-ray Absorbtimetry scan People with type 2 diabetes above 50 years Healthy controls Computerized dynamic posturography Healthy controls without diabetes Healthy controls Force Plate Platform Healthy controls without diabetes People with type 2 diabetes Handgrip strength People with type 2 diabetes above 50 years Healthy controls NCStat-DPN-Check Healthy controls without diabetes People with type 2 diabetes Force Plate Platform People with type 2 diabetes above 50 years Healthy controls Quantative Sensory Testing Healthy controls without diabetes Healthy controls Dual Energy X-ray Absorbtimetry scan Healthy controls without diabetes
- Primary Outcome Measures
Name Time Method Co-existence of peripheral- and vestiubular neuropathy in people with diabetes through study completion, an average of 2 years 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.
Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes through study completion, an average of 2 years 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.
- Secondary Outcome Measures
Name Time Method Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy through study completion, an average of 2 years QST / NC-Stat DPNCheck vs v-Hit
The impact of peripheral neuropathy on postural control (In quite stance) through study completion, an average of 2 years QST / Correlation between muscle strength and peripheral neuropathy vs Force Plate
Correlation between distal neuropathy and dynamic postural control (including patterns) through study completion, an average of 2 years QST / NC-Stat DPNCheck vs accelerometer / Bertec
Related Research Topics
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Trial Locations
- Locations (1)
Aalborg University Hospital
🇩🇰Aalborg, Denmark