Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus

Conditions
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Diabetes Mellitus, Vascular Complications, Mitochondrial Diseases

Intervention / Treatment
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* Other: examination: blood pressure assessment
* Other: examination: Flow Mediated Dilatation (FMD)-test
* Other: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring
* Other: examination: measurement of glucose by a finger prick


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participant<br>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<br>* blood pressure measurement for 30 minutes, dominant side<br>Other: examination: Flow Mediated Dilatation (FMD)-test<br>* Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality<br>Other: examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring<br>* participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation<br>Other: examination: measurement of glucose by a finger prick<br>* follow-up of blood sugar (glucose) during examinations by a finger prick<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, muscular oxygenation, vascular function