PREMOD: Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: examination: blood pressure assessment
blood pressure measurement for 30 minutes, dominant side
Other: examination: Flow Mediated Dilatation (FMD)-test
Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
Other: 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
Other: examination: measurement of glucose by a finger prick
follow-up of blood sugar (glucose) during examinations by a finger prick
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Gent, Rehabilitation Sciences | Ghent | Oost-Vlaanderen | Belgium | 9000 |
Sponsors and Collaborators
- University Ghent
- University Hospital, Ghent
Investigators
- Principal Investigator: Samyah Shadid, Prof. dr., University hospital of Ghent and University of Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B670201940995