Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Ghent
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Near-infrared spectroscopy during exercise
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
There is no masking because the participant knows his diagnosis. Besides, the investigator checks the blood sugar at different times during the examinations, so also the investigator is not blinded. In this study, blinding would have no additional value.
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: examination: blood pressure assessment (Other)
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.
Intervention: examination: Flow Mediated Dilatation (FMD)-test (Other)
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.
Intervention: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring (Other)
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.
Intervention: examination: measurement of glucose by a finger prick (Other)
Outcomes
Primary Outcomes
Near-infrared spectroscopy during exercise
Time Frame: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
analysis of changes in oxygenated blood during exercise
Flow Mediated Dilatation (FMD)-test
Time Frame: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
flow mediated dilatation test
exercise test wilt hand held dynamometer
Time Frame: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
analysis of strength and exercise capacity
Secondary Outcomes
- Blood pressure analysis(20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing))