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Diabetes nerve damage may disrupt the Brain's blood supply

NCT ID NCT04625751

Knowledge-focused Sponsor: Hartwig R. Siebner Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are investigating whether cardiovascular autonomic neuropathy, a form of nerve damage common in type 2 diabetes, is linked to problems with blood flow regulation in the brain. The study enrolls about 95 adults aged 50 to 70, some with this nerve damage and some without. Participants undergo MRI scans while breathing air with extra carbon dioxide and while viewing visual stimuli, plus a meal test to measure blood flow in the gut and hormone changes. The goal is to understand how nerve damage affects blood vessels in the brain and digestive system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If researchers find a link between diabetes nerve damage and poor blood flow control in the brain, it could guide future screening or treatments aimed at protecting brain health in people with type 2 diabetes.
What could go wrong
This is an observational study, so it can show associations but not prove cause and effect. The findings may not apply to younger people, those with type 1 diabetes, or patients taking heart or nerve medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

95 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with type 2 diabetes and cardiovascular autonomic neuropathy. Patients with type 2 diabetes but no cardiovascular autonomic neuropathy Healthy controls.

Ages

50 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

diabetic autonomic neuropathy type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular autonomic neuropathy Type 2 diabetes

Contacts and locations

Locations

  • Danish Research Centre for Magnetic Resonance

    Hvidovre, 2650, Denmark

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, 2820, Denmark

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