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NCT Number: NCT04625751

Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Cardiovascular Autonomic Neuropathy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center Copenhagen, Gentofte Municipality, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CO2-enriched air

Other

To assess cardiovascular reactivity

Meal response test

Other

Meal response test to assess changes in splanchnic blood flow.

Primary outcomes

  1. Neurovascular coupling

    Time frame: 1 hour

    Ratio between oxygen delivery/oxygen consumption by MRI during visual and hypercapnic stimulation

  2. Cerebrovascular reactivity

    Time frame: 1 hour

    Change in CBF between normocapnia and hypercapnia

  3. Structural differences in brain tissue

    Time frame: 1 hour

  4. Regional splanchnic blood (superior mesenteric artery) flow increase in response to meal test

    Time frame: 3 hours

  5. Change in blood levels of gastrointestinal hormones and markers of metabolism following meal test

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Hartwig R. Siebner

Other

Collaborators

  • Steno Diabetes Center Copenhagen

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2020
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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