E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This is a healthy control group which is to be compared with patients with stroke. |
Forsøgspersonerne fungerer som en kontrolgruppe for patienter med apopleksi. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061256 |
E.1.2 | Term | Ischaemic stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to investigate the effect of a single dose of 5 mikrogram GLP-1 receptor agonist ( exenatid ) on blood flow velocity and oxigination in persons without cerebrovascular disease. |
Formålet med dette forsøg er, at undersøge effekten af en enkeltdosis glukagon-lignende peptid 1 receptor agonist (GLP-1-RA) på blodgennemstrømningshastigheden og iltmætningen i hjernen hos personer uden cerebrovaskulær lidelse. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of this study is to investigate if the GLP-1 receptor agonist ( exenatid ) improves the peripheral endothelial function measured as an improved blood vessel respons in the fingers after a short occlusion of blood suply to the arm measured with endoPAT2000 and by measuring the blood pressure in the ancles (ancle-brachial index). Besides of that is the objective to examine the endothelial function and inflammation through specific biomarkers.
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Sekundære formål med forsøget er, at undersøge GLP-1-RAs virkning på blodkarfunktionen perifert på fingrene målt ved EndoPAT og perifert i anklerne målt som ankel-brachialindex (ABI), samt at undersøge endothelfunktion og inflammation via specifikke biomarkører. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Person ≥ 50 years of age • Has given written informed consent
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• Alder ≥ 50 år • Har afgivet skriftligt informeret samtykke
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E.4 | Principal exclusion criteria |
• Intracerebral haemorrhage • Subdural / epidural hemorrhage • subarachnoid haemorrhage • previously major structural damage to the brain (eg. sequelae after large stroke or brain surgery) • Type 1 diabetes • Type 2 diabetes • Known atrial fibrillation • > 50% stenosis of halskar • Known allergy to GLP-1 RA preparations • Hepatic impairment (ALT> 3 x upper normal limit) • Renal impairment (eGFR <30 ml / min) • Inflammatory bowel disease • Previous pancreatitis • Heart failure (NYHA class 3-4) • Pregnancy or lactation • Patient is not expected to co-operate to the investigations • Visualization of the middle cerebral artery bilaterally by transcraniel doppler not possible |
• Intracerebral blødning • Subdural/epidural blødning • Subarachnoidal blødning • Tidl. større strukturel skade på hjernen (eks. sequelae efter tidl. stor blodprop eller hjernekirurgi) • Type 1 sukkersyge • Type 2 sukkersyge • Kendt atrieflimmer • > 50% stenose af halskar • Kendt allergi overfor GLP-1-RA præparater • Nedsat leverfunktion (ALAT > 3 x øvre normalgrænse) • Nedsat nyrefunktion (eGFR < 30 ml/min) • Inflammatorisk tarmsygdom • Tidligere pancreatit • Hjertesvigt (NYHA klasse 3-4) • Graviditet eller amning • Patient der ikke forventes at kunne kooperere til undersøgelserne • Visualisering af a. cerebri media bilateralt ved TCD ej mulig
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is changes in the mean blood flow velocity (Vmean) in the middle cerebral artery and the cortical oxigination.
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Primær endpoint er ændringer i blodets middelstrømningshastighed (Vmean ) i a. cerebri media og cortikal iltmætning . |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to three hours after injection of exenatid. |
Op til tre timer efter injektion af exenatid. |
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E.5.2 | Secondary end point(s) |
- Changes in peripheral vascular function measured by EndoPAT and changes in the ancle-brachial index - Changes in inflammatory- and endothelial function markers in the blood. |
- Ændring i perifert karfunktion målt med EndoPAT og ændringer i ankelbrachial-indexet - Ændring af inflammatoriske- og karspecifikke markører i blodet.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to three hours after injection of exenatid. |
Op til tre timer efter injektion af exenatid. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |