Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
NCT ID: NCT04226820
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2020-02-01
2024-10-31
Brief Summary
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Both conditions will lead to a reduced flow of oxygen towards the muscle and this can have impact on the production of energy necessary for optimal functioning.
In this study, the investigators will examine the functionality of the blood vessels (1) and the uptake of oxygen into the muscles (2) in patients with diabetes mellitus type 1 and type 2 (with and without vascular complications) compared to healthy persons.
Detailed Description
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The examinations for this study consist of a blood pressure assessment, Flow Mediated Dilatation (FMD)-measurement, and a handgrip exercise test. The protocol will take approximately 2 hours.
The investigator who performs the FMD-test followed a course and passed thorough evaluation.
The blood pressure assessment will be continuously for 20 minutes to avoid large bias.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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participant
Participants are divided into 3 groups based on their diagnosis: diabetes mellitus type 1, diabetes mellitus type 2, and healthy persons. Each participant (independent of group) will have the same examinations. There is no retesting of the same participant in other conditions.
examination: blood pressure assessment
blood pressure measurement for 30 minutes, dominant side
examination: Flow Mediated Dilatation (FMD)-test
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring
participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation
examination: measurement of glucose by a finger prick
follow-up of blood sugar (glucose) during examinations by a finger prick
Interventions
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examination: blood pressure assessment
blood pressure measurement for 30 minutes, dominant side
examination: Flow Mediated Dilatation (FMD)-test
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring
participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation
examination: measurement of glucose by a finger prick
follow-up of blood sugar (glucose) during examinations by a finger prick
Eligibility Criteria
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Inclusion Criteria
* age 18-85 years old
* diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants
Exclusion Criteria
* alcohol abuse
* active cancer
* pregnancy
18 Years
85 Years
ALL
Yes
Sponsors
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University Hospital, Ghent
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Samyah Shadid, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
University hospital of Ghent and University of Ghent
Locations
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University Gent, Rehabilitation Sciences
Ghent, Oost-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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Anouk Tanghe, PhD
Role: primary
Other Identifiers
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B670201940995
Identifier Type: -
Identifier Source: org_study_id