The purpose of this study is to evaluate the vascular function and biomarkers in healthy volunteers and type 2 diabetic patients.
The present interventional study will be performed in 3 groups of healthy volunteers of different ages and in type 2 diabetic patients without an investigational medicinal product administrated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2. Then, subjects will be discharged at the end of the last investigation day (Day 2). All the participants have received two pharmacological agents (NIMP) : * Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function. * Adenosine : administered intravenously during MRI for the measurement of CFR.
Type 2 diabetic patients will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and CFR on Day 2. Then, subjects will be discharged at the end of the last investigation day (Day 2). All the participants have received two pharmacological agents (NIMP): * Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function. * Adenosine : administered intravenously during MRI for the measurement of CFR.
Nuvisan GmbH
Neu-Ulm, Germany
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Plasma/platelet levels of Dihydrobiopterin (BAH)/Tetrahydrobiopterin (BH4), Cyclic guanosine monophosphate (cGMP)
Time frame: Day 1
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Blood flow changes for vascular endothelial function
Time frame: Day 1
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Coronary flow reserve
Time frame: Day 2
Guanylate triphosphate cyclohydrolase (GTP-CH) investigations
Genomic market (blood) DNA and/or RNA characteristics of genes such as GTP Cyclohydrolase 1 (GCH)
Time frame: Day 1
Adverse events
Occurence of any adverse events
Time frame: Through study completion, 3.5 weeks
Blood pressure supine
Relevant abnormalities on supine blood pressure
Time frame: Day 1
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