Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes
NCT ID: NCT04625751
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
90 participants
OBSERVATIONAL
2021-04-07
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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T2DM +CAN
CO2-enriched air
To assess cardiovascular reactivity
Meal response test
Meal response test to assess changes in splanchnic blood flow.
T2DM -CAN
CO2-enriched air
To assess cardiovascular reactivity
Meal response test
Meal response test to assess changes in splanchnic blood flow.
Healthy control
CO2-enriched air
To assess cardiovascular reactivity
Meal response test
Meal response test to assess changes in splanchnic blood flow.
Interventions
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CO2-enriched air
To assess cardiovascular reactivity
Meal response test
Meal response test to assess changes in splanchnic blood flow.
Eligibility Criteria
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Inclusion Criteria
* Age between 50-70 years (All)
* Presence of CAN as diagnosed by cardiovascular reflex tests with two or three pathological results (Patients with CAN only)
* Exclusion of CAN as diagnosed by cardiovascular reflex tests with no pathological results (Patients without CAN and HC only)
Exclusion Criteria
* Acute infections (All)
* Thyroid disease (All)
* Substance or alcohol abuse (All)
* Atrial fibrillation or flutter (All)
* Respiratory failure (All)
* Participants in active laser treatment for retinopathy, will be excluded from the Valsalva test (Patients)
* 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)
* Claustrophobia (All)
* Implanted pacemakers or remaining pacemaker electrodes (All)
* Previous heart or brain surgery with use of metal clips (All)
* Any form of non-MR-compatible implants
* Non-compliance with the study protocol as judged by the investigators (All)
* Concurrent participation in an intervention study (Patients)
* Participants who by judgments of the investigator, is incapable of participating (All)
50 Years
70 Years
ALL
Yes
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Hartwig R. Siebner
OTHER
Responsible Party
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Hartwig R. Siebner
Professor, DMSc
Principal Investigators
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Hartwig R. Siebner, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Danish Research Centre for Magnetic Resonance
Locations
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Steno Diabetes Center Copenhagen
Gentofte Municipality, , Denmark
Danish Research Centre for Magnetic Resonance
Hvidovre, , Denmark
Countries
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Other Identifiers
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H-20031245
Identifier Type: -
Identifier Source: org_study_id
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