Clinical trial NCT04625751: Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes
Official title: Unravelling the Association Between Neurovascular Uncoupling and Autonomic Neuropathy in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 2 Diabetes
Cardiovascular Autonomic Neuropathy
Lead sponsor: Danish Research Centre for Magnetic Resonance
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Copenhagen
First posted: 2020-11-12
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes and cardiovascular autonomic neuropathy. Patients with type 2 diabetes but no cardiovascular autonomic neuropathy Healthy controls.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of type 2 diabetes (Patients)
* 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:

* Participants receiving treatment with direct effects on noradrenergic or cholinergic signaling (for example beta-blockers, tricyclic antidepressants, SSRI's) (All)
* 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)

Primary outcomes:
measure: Neurovascular coupling
timeFrame: 1 hour
measure: Cerebrovascular reactivity
timeFrame: 1 hour
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
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Hvidovre
country: Denmark
facility: Danish Research Centre for Magnetic Resonance
Study officials:
affiliation: Danish Research Centre for Magnetic Resonance
name: Hartwig R. Siebner, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: