Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-18 @ 4:20 AM
Study NCT ID:
NCT04625751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2020-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurovascular coupling', 'timeFrame': '1 hour', 'description': 'Ratio between oxygen delivery/oxygen consumption by MRI during visual and hypercapnic stimulation'}, {'measure': 'Cerebrovascular reactivity', 'timeFrame': '1 hour', 'description': 'Change in CBF between normocapnia and hypercapnia'}, {'measure': 'Structural differences in brain tissue', 'timeFrame': '1 hour'}, {'measure': 'Regional splanchnic blood (superior mesenteric artery) flow increase in response to meal test', 'timeFrame': '3 hours'}, {'measure': 'Change in blood levels of gastrointestinal hormones and markers of metabolism following meal test', 'timeFrame': '3 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Cardiovascular Autonomic Neuropathy']}, 'descriptionModule': {'briefSummary': 'Diabetes is a growing global health care challenge. Diabetes patients may also suffer from cardiovascular autonomic neuropathy (CAN) which may affect cerebral perfusion. The main purpose of this project is to investigate the association between CAN and disturbances in the neurovascular coupling in type 2 diabetes patients. Moreover, the purpose is also to investigate coherence between CAN and the enteric nervous system. Finally, this project aims at delineating microstructural changes in the brain tissues as a consequence of CAN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes and cardiovascular autonomic neuropathy. Patients with type 2 diabetes but no cardiovascular autonomic neuropathy Healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A diagnosis of type 2 diabetes (Patients)\n* Age between 50-70 years (All)\n* Presence of CAN as diagnosed by cardiovascular reflex tests with two or three pathological results (Patients with CAN only)\n* Exclusion of CAN as diagnosed by cardiovascular reflex tests with no pathological results (Patients without CAN and HC only)\n\nExclusion Criteria:\n\n* Participants receiving treatment with direct effects on noradrenergic or cholinergic signaling (for example beta-blockers, tricyclic antidepressants, SSRI's) (All)\n* Acute infections (All)\n* Thyroid disease (All)\n* Substance or alcohol abuse (All)\n* Atrial fibrillation or flutter (All)\n* Respiratory failure (All)\n* Participants in active laser treatment for retinopathy, will be excluded from the Valsalva test (Patients)\n* Non-diabetic causes of neuropathy including a medical history of vitamin B12 deficiency, folic acid deficiency, rheumatoid arthritics, amyloidosis, HIV, syphilis, Borreliosis, drug induced neuropathy and neuropathy caused by toxins (All)\n* Claustrophobia (All)\n* Implanted pacemakers or remaining pacemaker electrodes (All)\n* Previous heart or brain surgery with use of metal clips (All)\n* Any form of non-MR-compatible implants\n* Non-compliance with the study protocol as judged by the investigators (All)\n* Concurrent participation in an intervention study (Patients)\n* Participants who by judgments of the investigator, is incapable of participating (All)"}, 'identificationModule': {'nctId': 'NCT04625751', 'briefTitle': 'Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Danish Research Centre for Magnetic Resonance'}, 'officialTitle': 'Unravelling the Association Between Neurovascular Uncoupling and Autonomic Neuropathy in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'H-20031245'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T2DM +CAN', 'interventionNames': ['Other: CO2-enriched air', 'Other: Meal response test']}, {'label': 'T2DM -CAN', 'interventionNames': ['Other: CO2-enriched air', 'Other: Meal response test']}, {'label': 'Healthy control', 'interventionNames': ['Other: CO2-enriched air', 'Other: Meal response test']}], 'interventions': [{'name': 'CO2-enriched air', 'type': 'OTHER', 'description': 'To assess cardiovascular reactivity', 'armGroupLabels': ['Healthy control', 'T2DM +CAN', 'T2DM -CAN']}, {'name': 'Meal response test', 'type': 'OTHER', 'description': 'Meal response test to assess changes in splanchnic blood flow.', 'armGroupLabels': ['Healthy control', 'T2DM +CAN', 'T2DM -CAN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Copenhagen', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Danish Research Centre for Magnetic Resonance', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Hartwig R. Siebner, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Research Centre for Magnetic Resonance'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartwig R. Siebner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, DMSc', 'investigatorFullName': 'Hartwig R. Siebner', 'investigatorAffiliation': 'Danish Research Centre for Magnetic Resonance'}}}}