Diabetic Peripheral NeuropathyDIAFALLNCT05389566
Diabetes, Falls, and Fractures
An observational study of Diabetic Peripheral Neuropathy and Diabetes, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetes, Balance; Distorted
- What is being tested?
- Quantative Sensory Testing, NCStat-DPN-Check and Composite Autonomic Symptom Score 31
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes, Balance; Distorted, Vestibular Neuropathy, Muscle Weakness, Sarcopenia
- Being tested
- Quantative Sensory Testing, NCStat-DPN-Check, Composite Autonomic Symptom Score 31, Computerized dynamic posturography, Video Head Impulse Test
- Keywords
- Diabetes, Balance, Vestibular, Neuropathy, Muscle Weakness, Autonomic Neuropathy, Small Fiber Neuropathy, Postural control
- Medical subject headings
- Diabetes Mellitus, Vestibular Neuronitis, Muscle Weakness, Sarcopenia, Diabetic Neuropathies, Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantative Sensory TestingDiagnostic test
Evaluation of small fiber neuropathy
NCStat-DPN-CheckDiagnostic test
Evaluation of large fiber neuropathy
Composite Autonomic Symptom Score 31Diagnostic test
Evaluation of autonomic neuropathy
Computerized dynamic posturographyDiagnostic test
Also called Bertec
Evaluation of dynamic postural control
Video Head Impulse TestDiagnostic test
Also called V-Hit
Evaluation of vertigo and the vestibular organ
AccelerometerDiagnostic test
Also called Sens Innovation, Copenhagen Denmark
Evaluation of gait pattern
Handgrip strengthDiagnostic test
Also called Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea
Evaluation of muscle strength
Dual Energy X-ray Absorbtimetry scanDiagnostic test
Also called Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA)
Evaluation of body composition
Force Plate PlatformDiagnostic test
Also called Plux Biosignals, S.A, Arruda dos Vinhos, Portugal
Evaluation of balance while standing still
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | People with type 1 diabetes above 40 years Receives: 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 | People with type 2 diabetes above 50 years Receives: 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 | Healthy controls without diabetes Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start6 May 2022
- Primary completion20 May 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Nicklas Højgaard-hessellund Rasmussen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389566
- Sponsor's protocol ID
- N-20190004
- Acronym
- DIAFALL
- Status last verified
- Aug 2024
- First submitted
- 6 May 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Possible requirement for external data analysis
Publications
Mahalingasivam AA, Jespersen AK, Ejskjaer N, Hougaard DD, Vestergaard P, Rasmussen NH, Roikjer J. The co-existence of peripheral and vestibular neuropathy in diabetes: a cross-sectional study. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):663-672. doi: 10.1007/s00405-023-08130-6. Epub 2023 Jul 29.
PubMed 37515636
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes, Falls, and Fractures
- ClinicalTrials.gov ID
- NCT05389566
- Acronym / sponsor ID
- DIAFALL / N-20190004
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes, Balance; Distorted, Vestibular Neuropathy, Muscle Weakness, Sarcopenia
- Keywords
- Diabetes, Balance, Vestibular, Neuropathy, Muscle Weakness, Autonomic Neuropathy, Small Fiber Neuropathy, Postural control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 6 May 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 1 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 PlatformPeople with type 1 diabetes above 40 years |
| People with type 2 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 PlatformPeople with type 2 diabetes above 50 years |
| Healthy controls | – | 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 PlatformHealthy controls without diabetes |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantative Sensory TestingEvaluation of small fiber neuropathy | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| NCStat-DPN-CheckEvaluation of large fiber neuropathy | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| Composite Autonomic Symptom Score 31Evaluation of autonomic neuropathy | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| Computerized dynamic posturographyAlso: BertecEvaluation of dynamic postural control | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| Video Head Impulse TestAlso: V-HitEvaluation of vertigo and the vestibular organ | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| AccelerometerAlso: Sens Innovation, Copenhagen DenmarkEvaluation of gait pattern | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| Handgrip strengthAlso: Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South KoreaEvaluation of muscle strength | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| Dual Energy X-ray Absorbtimetry scanAlso: Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA)Evaluation of body composition | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
| Force Plate PlatformAlso: Plux Biosignals, S.A, Arruda dos Vinhos, PortugalEvaluation of balance while standing still | Diagnostic test | Healthy controls, People with type 2 diabetes, Type 1 diabetes |
Primary outcome
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.
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.
3 secondary outcomes
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
Correlation between distal neuropathy and dynamic postural control (including patterns)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 37515636Mahalingasivam AA, Jespersen AK, Ejskjaer N, Hougaard DD, Vestergaard P, Rasmussen NH, Roikjer J. The co-existence of peripheral and vestibular neuropathy in diabetes: a cross-sectional study. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):663-672. doi: 10.1007/s00405-023-08130-6. Epub 2023 Jul 29.
- Individual participant dataSharing planned: Undecided. Possible requirement for external data analysis
Related trials for Diabetic Peripheral Neuropathy
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Recruiting
Acupuncture Plus Mecobalamin for Diabetic Cardiac Autonomic Neuropathy
Diabetic Cardiovascular Autonomic Neuropathy, Type 2 Diabetes Mellitus
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy and Diabetes, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-existence of peripheral- and vestiubular neuropathy in people with diabetes (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.