Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

Hartwig R. Siebner

Status

Active, not recruiting

Conditions

Cardiovascular Autonomic Neuropathy

Type 2 Diabetes

Treatments

Other: CO2-enriched air

Other: Meal response test

Study type

Observational

Funder types

Other

Identifiers

NCT04625751

H-20031245

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)