NCT04625751Completed
Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes
Unravelling the Association Between Neurovascular Uncoupling and Autonomic Neuropathy in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 95 (actual)
- First submitted
- 6 Nov 2020
- Start date
- 7 Apr 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Hartwig R. Siebner
- Diseases
- Type 2 diabetes
- NCT number
- NCT04625751
What you commit to
- Study type: Observational
- Participants enrolled: 95
- From 7 Apr 2021 to the primary completion date, 31 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants receiving treatment with direct effects on noradrenergic or cholinergic signaling (for example beta-blockers, tricyclic antidepressants, SSRI's) (All)
- Previous heart or brain surgery with use of metal clips (All)
- Any form of non-MR-compatible implants
- Concurrent participation in an intervention study (Patients)
Other illness
- Acute infections (All)
- Thyroid disease (All)
- Respiratory failure (All)
- 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)
Other
- Substance or alcohol abuse (All)
- Atrial fibrillation or flutter (All)
- Participants in active laser treatment for retinopathy, will be excluded from the Valsalva test (Patients)
- Claustrophobia (All)
- Implanted pacemakers or remaining pacemaker electrodes (All)
- Non-compliance with the study protocol as judged by the investigators (All)
- Participants who by judgments of the investigator, is incapable of participating (All)
Who the study is looking for
- 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)
Age in the registry: 50 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Gentofte Municipality | Denmark | Unknown status |
| Danish Research Centre for Magnetic Resonance Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.