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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participant | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| examination: blood pressure assessment | Other | blood pressure measurement for 30 minutes, dominant side |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilatation (FMD)-test | flow mediated dilatation test | 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing) |
| Near-infrared spectroscopy during exercise | analysis of changes in oxygenated blood during exercise | 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing) |
| exercise test wilt hand held dynamometer | analysis of strength and exercise capacity | 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure analysis | measurement of basal blood pressure (systolic and diastolic) | 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anouk Tanghe, PhD | Contact | +32 09 332 36 27 | anouk.tanghe@ugent.be | |
| Patrick Calders, Prof. dr. | Contact | +32 09 332 69 15 | patrick.calders@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Samyah Shadid, Prof. dr. | University hospital of Ghent and University of Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Gent, Rehabilitation Sciences | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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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.
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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.
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| examination: Flow Mediated Dilatation (FMD)-test | Other | Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality |
|
| examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring | Other | 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 | Other | follow-up of blood sugar (glucose) during examinations by a finger prick |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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