Diabetes, Falls, and Fractures (DIAFALL)
August 7, 2024 updated by: Nicklas Højgaard-hessellund Rasmussen, Aalborg University Hospital
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Diagnostic test: Handgrip strength
- 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: Dual Energy X-ray Absorbtimetry scan
- Diagnostic test: Force Plate Platform
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalborg, Denmark, 9000
- Aalborg University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Type 1 diabetes
People with type 1 diabetes above 40 years
|
Evaluation of muscle strength
Other Names:
Evaluation of small fiber neuropathy
Evaluation of large fiber neuropathy
Evaluation of autonomic neuropathy
Evaluation of dynamic postural control
Other Names:
Evaluation of vertigo and the vestibular organ
Other Names:
Evaluation of gait pattern
Other Names:
Evaluation of body composition
Other Names:
Evaluation of balance while standing still
Other Names:
|
|
People with type 2 diabetes
People with type 2 diabetes above 50 years
|
Evaluation of muscle strength
Other Names:
Evaluation of small fiber neuropathy
Evaluation of large fiber neuropathy
Evaluation of autonomic neuropathy
Evaluation of dynamic postural control
Other Names:
Evaluation of vertigo and the vestibular organ
Other Names:
Evaluation of gait pattern
Other Names:
Evaluation of body composition
Other Names:
Evaluation of balance while standing still
Other Names:
|
|
Healthy controls
Healthy controls without diabetes
|
Evaluation of muscle strength
Other Names:
Evaluation of small fiber neuropathy
Evaluation of large fiber neuropathy
Evaluation of autonomic neuropathy
Evaluation of dynamic postural control
Other Names:
Evaluation of vertigo and the vestibular organ
Other Names:
Evaluation of gait pattern
Other Names:
Evaluation of body composition
Other Names:
Evaluation of balance while standing still
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Co-existence of peripheral- and vestiubular neuropathy in people with diabetes
Time Frame: 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.
|
through study completion, an average of 2 years
|
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Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes
Time Frame: 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.
|
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
Time Frame: through study completion, an average of 2 years
|
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)
Time Frame: through study completion, an average of 2 years
|
QST / NC-Stat DPNCheck vs accelerometer / Bertec
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through study completion, an average of 2 years
|
|
The impact of peripheral neuropathy on postural control (In quite stance)
Time Frame: through study completion, an average of 2 years
|
QST / Correlation between muscle strength and peripheral neuropathy vs Force Plate
|
through study completion, an average of 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory
Time Frame: through study completion, an average of 2 years
|
accelerometer (SENS Innovation, Copenhagen, Denmark) measures (postural control during walking)
|
through study completion, an average of 2 years
|
|
Exploratory
Time Frame: through study completion, an average of 2 years
|
Correlations between different outcomes of Bertec and v-Hit vs peripheral neuropathy (all individual examinations and arcways)
|
through study completion, an average of 2 years
|
|
Muscle strength and peripheral neuropathy
Time Frame: 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
|
through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2022
Primary Completion (Actual)
May 20, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
May 6, 2022
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
August 9, 2024
Last Update Submitted That Met QC Criteria
August 7, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Otorhinolaryngologic Diseases
- Neuromuscular Manifestations
- Ear Diseases
- Pathological Conditions, Anatomical
- Cranial Nerve Diseases
- Muscular Atrophy
- Atrophy
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Diabetes Mellitus
- Muscle Weakness
- Peripheral Nervous System Diseases
- Sarcopenia
- Diabetic Neuropathies
- Paresis
- Small Fiber Neuropathy
- Vestibular Neuronitis
Other Study ID Numbers
- N-20190004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Possible requirement for external data analysis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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