Neurovascular Coupling and Autonomic Neuropathy in Type 2... | NCT04625751

Studies
Neurovascular Coupling and Autonomic Neuropathy in Type 2 Diabetes

NCT04625751

Sponsor

Hartwig R. Siebner

Status

Unknown status

Last Update Posted

Apr 12, 2024Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Type 2 Diabetes
Cardiovascular Autonomic Neuropathy

Interventions

CO2-enriched air
Meal response test

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 7, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jul 31, 2025Estimated

First Submitted Date

Nov 6, 2020

First Submission Date that Met QC Criteria

Nov 6, 2020

First Posted Date

Nov 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2024

Last Update Posted Date

Apr 12, 2024Actual

Name	Class
Steno Diabetes Center Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CO2-enriched air	Other	To assess cardiovascular reactivity	Healthy control T2DM +CAN T2DM -CAN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Steno Diabetes Center Copenhagen		Gentofte Municipality		2820	Denmark
Danish Research Centre for Magnetic Resonance

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases