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Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

Unravelling the Association Between Neurovascular Uncoupling and Autonomic Neuropathy in Patients With Type 2 Diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04625751
Enrollment
90
Registered
2020-11-12
Start date
2021-04-07
Completion date
2025-07-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Autonomic Neuropathy, Type 2 Diabetes

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.

Interventions

OTHERCO2-enriched air

To assess cardiovascular reactivity

OTHERMeal response test

Meal response test to assess changes in splanchnic blood flow.

Sponsors

Steno Diabetes Center Copenhagen
CollaboratorOTHER
Hartwig R. Siebner
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Neurovascular coupling1 hourRatio between oxygen delivery/oxygen consumption by MRI during visual and hypercapnic stimulation
Cerebrovascular reactivity1 hourChange in CBF between normocapnia and hypercapnia
Structural differences in brain tissue1 hour
Regional splanchnic blood (superior mesenteric artery) flow increase in response to meal test3 hours
Change in blood levels of gastrointestinal hormones and markers of metabolism following meal test3 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026