Clinical trial NCT04226820: Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Official title: Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Vascular Complications
Mitochondrial Diseases
Keywords: diabetes mellitus
muscular oxygenation
vascular function
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2020-01-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: Oxygen is required for an optimal muscle function. In patients with diabetes mellitus, hyperglycemia can cause vascular complications. The endothelium (inter layer of the blood vessels) can be damaged leading to a reduced oxygen flow towards the muscle cells. Besides, it is possible that mitochondrial dysfunction is occuring leading to reduced extraction of oxygen.

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: The investigators plan to recruit in total 125 participants who will be divided into 3 main groups: (I) diabetes mellitus type 1 (with (a) or without (b) vascular complications), (II) diabetes mellitus type 2 (with (a) or without (b) vascular complications), and (III) healthy persons. Diabetes mellitus will be defined by the guidelines of the American Diabetes Association (ADA).

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.

Eligibility criteria: Inclusion Criteria:

* men and women
* age 18-85 years old
* diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants

Exclusion Criteria:

* other types of diabetes mellitus than type 1 or type 2
* alcohol abuse
* active cancer
* pregnancy

Primary outcomes:
measure: Flow Mediated Dilatation (FMD)-test
timeFrame: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
measure: Near-infrared spectroscopy during exercise
timeFrame: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
measure: exercise test wilt hand held dynamometer
timeFrame: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Secondary outcomes:
measure: Blood pressure analysis
timeFrame: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Gent, Rehabilitation Sciences
state: Oost-Vlaanderen
Study officials:
affiliation: University hospital of Ghent and University of Ghent
name: Samyah Shadid, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: