Type 2 DiabetesNCT04625751
Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes
An observational study of Type 2 Diabetes and Cardiovascular Autonomic Neuropathy, run by Hartwig R. Siebner at 2 sites in Denmark.
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… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Autonomic Neuropathy
- What is being tested?
- CO2-enriched air and Meal response test
- How many people
- 95 participants
- Where
- 2 sitesDenmark
- Study dates
- 7 Apr 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with type 2 diabetes and cardiovascular autonomic neuropathy. Patients with type 2 diabetes but no cardiovascular autonomic neuropathy Healthy controls.
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 15Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820
Danish Research Centre for Magnetic Resonance
Hvidovre, 2650
About this study
Official title: Unravelling the Association Between Neurovascular Uncoupling and Autonomic Neuropathy in Patients With 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.
- Being tested
- CO2-enriched air, Meal response test
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2-enriched airOther
To assess cardiovascular reactivity
Meal response testOther
Meal response test to assess changes in splanchnic blood flow.
| Study group | Role | What they receive |
|---|---|---|
| T2DM +CAN | Not described Receives: Other: CO2-enriched air; Other: Meal response test | |
| T2DM -CAN | Not described Receives: Other: CO2-enriched air; Other: Meal response test | |
| Healthy control | Not described Receives: Other: CO2-enriched air; Other: Meal response test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurovascular coupling
Ratio between oxygen delivery/oxygen consumption by MRI during visual and hypercapnic stimulation
Measured: 1 hour
Cerebrovascular reactivity
Change in CBF between normocapnia and hypercapnia
Measured: 1 hour
Structural differences in brain tissue
Measured: 1 hour
Regional splanchnic blood (superior mesenteric artery) flow increase in response to meal test
Measured: 3 hours
Change in blood levels of gastrointestinal hormones and markers of metabolism following meal test
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start7 Apr 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartwig R. Siebner
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Responsible party
- Sponsor-investigator, Hartwig R. Siebner, Danish Research Centre for Magnetic Resonance
- Investigators
- Hartwig R. Siebner, MD, Prof, Principal investigator, Danish Research Centre for Magnetic Resonance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625751
- Sponsor's protocol ID
- H-20031245
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unravelling the Association Between Neurovascular Uncoupling and Autonomic Neuropathy in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04625751
- Acronym / sponsor ID
- H-20031245
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hartwig R. SiebnerUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2DM +CAN | – | Other: CO2-enriched air, Other: Meal response test |
| T2DM -CAN | – | Other: CO2-enriched air, Other: Meal response test |
| Healthy control | – | Other: CO2-enriched air, Other: Meal response test |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes and cardiovascular autonomic neuropathy. Patients with type 2 diabetes but no cardiovascular autonomic neuropathy Healthy controls.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2-enriched airTo assess cardiovascular reactivity | Other | Healthy control, T2DM +CAN, T2DM -CAN |
| Meal response testMeal response test to assess changes in splanchnic blood flow. | Other | Healthy control, T2DM +CAN, T2DM -CAN |
Primary outcome
Neurovascular coupling
Time frame: 1 hour
Ratio between oxygen delivery/oxygen consumption by MRI during visual and hypercapnic stimulation
Cerebrovascular reactivity
Time frame: 1 hour
Change in CBF between normocapnia and hypercapnia
Structural differences in brain tissue
Time frame: 1 hour
Regional splanchnic blood (superior mesenteric artery) flow increase in response to meal test
Time frame: 3 hours
Change in blood levels of gastrointestinal hormones and markers of metabolism following meal test
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hartwig R. Siebner, MD, Prof principal investigator
Danish Research Centre for Magnetic Resonance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Cardiovascular Autonomic Neuropathy, run by Hartwig R. Siebner at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurovascular coupling (time frame: 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.