Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04625751
• Other study ID #: H-20031245
• Status: Active, not recruiting
• Start date: April 7, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Danish Research Centre for Magnetic Resonance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Autonomic Neuropathy
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Nervous System Diseases
• Type 2 Diabetes

Intervention

Other:
• CO2-enriched air
To assess cardiovascular reactivity
• Meal response test
Meal response test to assess changes in splanchnic blood flow.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte
Denmark	Danish Research Centre for Magnetic Resonance	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hartwig R. Siebner	Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurovascular coupling	Ratio between oxygen delivery/oxygen consumption by MRI during visual and hypercapnic stimulation	1 hour
Primary	Cerebrovascular reactivity	Change in CBF between normocapnia and hypercapnia	1 hour
Primary	Structural differences in brain tissue		1 hour
Primary	Regional splanchnic blood (superior mesenteric artery) flow increase in response to meal test		3 hours
Primary	Change in blood levels of gastrointestinal hormones and markers of metabolism following meal test		3 hours