NCT05389566

Brief Summary

Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

14 days

First QC Date

May 6, 2022

Last Update Submit

August 7, 2024

Conditions

Diabetic Peripheral NeuropathyDiabetesBalance; DistortedVestibular NeuropathyMuscle WeaknessSarcopeniaAutonomic Neuropathy, DiabeticSmall Fiber Neuropathy

Keywords

DiabetesBalanceVestibularNeuropathyMuscle WeaknessAutonomic NeuropathySmall Fiber NeuropathyPostural control

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    through study completion, an average of 2 years

  • Correlation between distal neuropathy and dynamic postural control (including patterns)

    through study completion, an average of 2 years

  • The impact of peripheral neuropathy on postural control (In quite stance)

    through study completion, an average of 2 years

Other Outcomes (3)

  • Exploratory

    through study completion, an average of 2 years

  • Exploratory

    through study completion, an average of 2 years

  • Muscle strength and peripheral neuropathy

    through study completion, an average of 2 years

Study Arms (3)

Type 1 diabetes

People with type 1 diabetes above 40 years

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

People with type 2 diabetes

People with type 2 diabetes above 50 years

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

Healthy controls

Healthy controls without diabetes

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

Interventions

Quantative Sensory TestingDIAGNOSTIC_TEST

Evaluation of small fiber neuropathy

Healthy controlsPeople with type 2 diabetesType 1 diabetes
NCStat-DPN-CheckDIAGNOSTIC_TEST

Evaluation of large fiber neuropathy

Healthy controlsPeople with type 2 diabetesType 1 diabetes
Composite Autonomic Symptom Score 31DIAGNOSTIC_TEST

Evaluation of autonomic neuropathy

Healthy controlsPeople with type 2 diabetesType 1 diabetes
Computerized dynamic posturographyDIAGNOSTIC_TEST

Evaluation of dynamic postural control

Also known as: Bertec
Healthy controlsPeople with type 2 diabetesType 1 diabetes
Video Head Impulse TestDIAGNOSTIC_TEST

Evaluation of vertigo and the vestibular organ

Also known as: V-Hit
Healthy controlsPeople with type 2 diabetesType 1 diabetes
AccelerometerDIAGNOSTIC_TEST

Evaluation of gait pattern

Also known as: Sens Innovation, Copenhagen Denmark
Healthy controlsPeople with type 2 diabetesType 1 diabetes
Handgrip strengthDIAGNOSTIC_TEST

Evaluation of muscle strength

Also known as: Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea
Healthy controlsPeople with type 2 diabetesType 1 diabetes
Dual Energy X-ray Absorbtimetry scanDIAGNOSTIC_TEST

Evaluation of body composition

Also known as: Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA)
Healthy controlsPeople with type 2 diabetesType 1 diabetes
Force Plate PlatformDIAGNOSTIC_TEST

Evaluation of balance while standing still

Also known as: Plux Biosignals, S.A, Arruda dos Vinhos, Portugal
Healthy controlsPeople with type 2 diabetesType 1 diabetes

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark

You may qualify if:

  • Men and women with minimum 40 years of age and maximum 70 years of age.
  • Diagnosis of T1D or T2D
  • Signed the informed consent.

You may not qualify if:

  • 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
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 37515636DERIVED

MeSH Terms

Conditions

Diabetes MellitusVestibular NeuronitisMuscle WeaknessSarcopeniaDiabetic NeuropathiesSmall Fiber Neuropathy

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesCranial Nerve DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular AtrophyAtrophyPathological Conditions, AnatomicalPeripheral Nervous System DiseasesNeuromuscular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc and researcher

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 25, 2022

Study Start

May 6, 2022

Primary Completion

May 20, 2022

Study Completion

September 1, 2022

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

DK(1)