Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 5:03 AM
Study NCT ID:
NCT05389566
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes, Falls, and Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D020338', 'term': 'Vestibular Neuronitis'}, {'id': 'D018908', 'term': 'Muscle Weakness'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D000071075', 'term': 'Small Fiber Neuropathy'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'accelerometer (SENS Innovation, Copenhagen, Denmark) measures (postural control during walking)'}, {'measure': 'Exploratory', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Correlations between different outcomes of Bertec and v-Hit vs peripheral neuropathy (all individual examinations and arcways)'}, {'measure': 'Muscle strength and peripheral neuropathy', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Correlation between muscle strength and peripheral neuropathy (DEXA-scans, hand grup strength, QST, Correlation between muscle strength and peripheral neuropathy'}], 'primaryOutcomes': [{'measure': 'Co-existence of peripheral- and vestiubular neuropathy in people with diabetes', 'timeFrame': 'through study completion, an average of 2 years', 'description': '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.'}, {'measure': 'Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes', 'timeFrame': 'through study completion, an average of 2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'QST / NC-Stat DPNCheck vs v-Hit'}, {'measure': 'Correlation between distal neuropathy and dynamic postural control (including patterns)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'QST / NC-Stat DPNCheck vs accelerometer / Bertec'}, {'measure': 'The impact of peripheral neuropathy on postural control (In quite stance)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'QST / Correlation between muscle strength and peripheral neuropathy vs Force Plate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Balance', 'Vestibular', 'Neuropathy', 'Muscle Weakness', 'Autonomic Neuropathy', 'Small Fiber Neuropathy', 'Postural control'], 'conditions': ['Diabetic Peripheral Neuropathy', 'Diabetes', 'Balance; Distorted', 'Vestibular Neuropathy', 'Muscle Weakness', 'Sarcopenia', 'Autonomic Neuropathy, Diabetic', 'Small Fiber Neuropathy']}, 'referencesModule': {'references': [{'pmid': '37515636', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with type 1 or 2 diabetes from general practice or outpatient clinic at Steno Diabetes Center North Denmark', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women with minimum 40 years of age and maximum 70 years of age.\n2. Diagnosis of T1D or T2D\n3. Diagnosis of diabetes with at least one year prior to inclusion of the study\n4. Signed the informed consent.\n\nExclusion Criteria:\n\n1. Severe decreased liver function (Alanin amino-transaminase (ALAT)\\>250u/l, GammaGlutamyltransferase (GGT)\\>150u/l)\n2. Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) \\<15mmol/L/1,73m2\n3. Pregnancy or breast feeding\n4. Active malignancy or terminal ill.\n5. Current or previous alcohol- or drug abuse\n\n8\\. 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.'}, 'identificationModule': {'nctId': 'NCT05389566', 'acronym': 'DIAFALL', 'briefTitle': 'Diabetes, Falls, and Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Diabetes, Falls, and Fractures', 'orgStudyIdInfo': {'id': 'N-20190004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 diabetes', 'description': 'People with type 1 diabetes above 40 years', 'interventionNames': ['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']}, {'label': 'People with type 2 diabetes', 'description': 'People with type 2 diabetes above 50 years', 'interventionNames': ['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']}, {'label': 'Healthy controls', 'description': 'Healthy controls without diabetes', 'interventionNames': ['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']}], 'interventions': [{'name': 'Quantative Sensory Testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of small fiber neuropathy', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'NCStat-DPN-Check', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of large fiber neuropathy', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'Composite Autonomic Symptom Score 31', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of autonomic neuropathy', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'Computerized dynamic posturography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Bertec'], 'description': 'Evaluation of dynamic postural control', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'Video Head Impulse Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['V-Hit'], 'description': 'Evaluation of vertigo and the vestibular organ', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'Accelerometer', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Sens Innovation, Copenhagen Denmark'], 'description': 'Evaluation of gait pattern', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'Handgrip strength', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Hydraulic dynamometer, Saehan Coorporation, Gyungnam, South Korea'], 'description': 'Evaluation of muscle strength', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'Dual Energy X-ray Absorbtimetry scan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Dexa, Hollogic Horizon (4500 Hollogic Inc., Marlborough, MA, USA)'], 'description': 'Evaluation of body composition', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}, {'name': 'Force Plate Platform', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Plux Biosignals, S.A, Arruda dos Vinhos, Portugal'], 'description': 'Evaluation of balance while standing still', 'armGroupLabels': ['Healthy controls', 'People with type 2 diabetes', 'Type 1 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Possible requirement for external data analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc and researcher', 'investigatorFullName': 'Nicklas Højgaard-hessellund Rasmussen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}