Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

Active, not recruiting

• Conditions: Type 2 Diabetes; Cardiovascular Autonomic Neuropathy
• Interventions: Other: CO2-enriched air; Other: Meal response test

• Registration Number: NCT04625751
• Lead Sponsor: Hartwig R. Siebner

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-12
• Study Start: 2021-04-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM +CAN	Meal response test	-
Healthy control	CO2-enriched air	-
T2DM -CAN	Meal response test	-
T2DM -CAN	CO2-enriched air	-
Healthy control	Meal response test	-
T2DM +CAN	CO2-enriched air	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Steno Diabetes Center Copenhagen; 🇩🇰 Gentofte, Denmark

Danish Research Centre for Magnetic Resonance; 🇩🇰 Hvidovre, Denmark