Diabetes Mellitus, Mitochondrial Diseases, Vascular Complications
Conditions
Keywords
diabetes mellitus, muscular oxygenation, vascular function
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.
Interventions
OTHERexamination: blood pressure assessment
blood pressure measurement for 30 minutes, dominant side
OTHERexamination: Flow Mediated Dilatation (FMD)-test
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
OTHERexamination: 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
OTHERexamination: measurement of glucose by a finger prick
follow-up of blood sugar (glucose) during examinations by a finger prick
Sponsors
University Hospital, Ghent
University Ghent
Study design
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilatation (FMD)-test | 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing) | flow mediated dilatation test |
| Near-infrared spectroscopy during exercise | 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 |
| exercise test wilt hand held dynamometer | 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing) | analysis of strength and exercise capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure analysis | 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing) | measurement of basal blood pressure (systolic and diastolic) |
Countries
Belgium
Contacts
Primary ContactAnouk Tanghe, PhD
Backup ContactPatrick Calders, Prof. dr.
Outcome results
None listed