An observational study in Diabetic Peripheral Neuropathy, Diabetes and Balance; Distorted, sponsored by Aalborg University Hospital. Completed at 1 site in Denmark. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Aalborg University Hospital · Observational
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
This study's enrollment of 110 is close to the median of 104 across 68 observational studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Compared within Diabetic Neuropathies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People with type 1 diabetes above 40 years
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
People with type 2 diabetes above 50 years
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
Healthy controls without diabetes
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
Evaluation of small fiber neuropathy
Evaluation of large fiber neuropathy
Evaluation of autonomic neuropathy
Evaluation of dynamic postural control
Also known as: Bertec
Evaluation of vertigo and the vestibular organ
Also known as: V-Hit
Evaluation of gait pattern
Also known as: Sens Innovation, Copenhagen Denmark
Evaluation of muscle strength
Also known as: Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea
Evaluation of body composition
Also known as: Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA)
Evaluation of balance while standing still
Also known as: Plux Biosignals, S.A, Arruda dos Vinhos, Portugal
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.
Time frame: 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.
Time frame: through study completion, an average of 2 years
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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 2 years
Exploratory
accelerometer (SENS Innovation, Copenhagen, Denmark) measures (postural control during walking)
Time frame: 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)
Time frame: 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
Time frame: through study completion, an average of 2 years
Plan to share: Undecided — Possible requirement for external data analysis
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in May 2022, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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