NCT04625751

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

3.7 years

First QC Date

November 6, 2020

Last Update Submit

April 11, 2024

Conditions

Type 2 DiabetesCardiovascular Autonomic Neuropathy

Outcome Measures

Primary Outcomes (5)

  • Neurovascular coupling

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

    1 hour

  • Cerebrovascular reactivity

    Change in CBF between normocapnia and hypercapnia

    1 hour

  • Structural differences in brain tissue

    1 hour

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

    3 hours

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

    3 hours

Study Arms (3)

T2DM +CAN

Other: CO2-enriched airOther: Meal response test

T2DM -CAN

Other: CO2-enriched airOther: Meal response test

Healthy control

Other: CO2-enriched airOther: Meal response test

Interventions

CO2-enriched airOTHER

To assess cardiovascular reactivity

Healthy controlT2DM +CANT2DM -CAN
Meal response testOTHER

Meal response test to assess changes in splanchnic blood flow.

Healthy controlT2DM +CANT2DM -CAN

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Danish Research Centre for Magnetic Resonance

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hartwig R. Siebner, MD, Prof

    Danish Research Centre for Magnetic Resonance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

April 7, 2021

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations

DK(2)