Diabetic Peripheral Neuropathy, Diabetes, Balance; Distorted, Vestibular Neuropathy, Muscle Weakness, Sarcopenia, Autonomic Neuropathy, Diabetic, Small Fiber Neuropathy
Conditions
Keywords
Diabetes, Balance, Vestibular, Neuropathy, Muscle Weakness, Autonomic Neuropathy, Small Fiber Neuropathy, Postural control
Brief summary
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
Interventions
DIAGNOSTIC_TESTQuantative Sensory Testing
Evaluation of small fiber neuropathy
DIAGNOSTIC_TESTNCStat-DPN-Check
Evaluation of large fiber neuropathy
DIAGNOSTIC_TESTComposite Autonomic Symptom Score 31
Evaluation of autonomic neuropathy
DIAGNOSTIC_TESTComputerized dynamic posturography
Evaluation of dynamic postural control
DIAGNOSTIC_TESTVideo Head Impulse Test
Evaluation of vertigo and the vestibular organ
DIAGNOSTIC_TESTAccelerometer
Evaluation of gait pattern
DIAGNOSTIC_TESTHandgrip strength
Evaluation of muscle strength
DIAGNOSTIC_TESTDual Energy X-ray Absorbtimetry scan
Evaluation of body composition
DIAGNOSTIC_TESTForce Plate Platform
Evaluation of balance while standing still
Sponsors
Aalborg University
Aalborg University Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women with minimum 40 years of age and maximum 70 years of age. 2. Diagnosis of T1D or T2D 3. Diagnosis of diabetes with at least one year prior to inclusion of the study 4. Signed the informed consent.
Exclusion criteria
1. Severe decreased liver function (Alanin amino-transaminase (ALAT)\>250u/l, GammaGlutamyltransferase (GGT)\>150u/l) 2. Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) \<15mmol/L/1,73m2 3. Pregnancy or breast feeding 4. Active malignancy or terminal ill. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory | through study completion, an average of 2 years | accelerometer (SENS Innovation, Copenhagen, Denmark) measures (postural control during walking) |
| Muscle strength and peripheral neuropathy | through study completion, an average of 2 years | Correlation between muscle strength and peripheral neuropathy (DEXA-scans, hand grup strength, QST, Correlation between muscle strength and peripheral neuropathy |
Countries
Denmark
Outcome results
None listed