Vascular Dysfunction in Paediatric IBD
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|ClinicalTrials.gov Identifier: NCT02161640|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : February 23, 2017
Inflammatory Bowel Diseases (IBD) is a group of relapsing and remitting gut inflammatory conditions acquired due to genetic susceptibility and/or environmental triggers. The disease manifestations are being increasingly seen in young children and the life-long debilitation has a severe effect on quality of life. Limited evidence suggests, although rare, in some young IBD individuals vascular complications may ensue. This leads to increased risk of vascular problems such as thrombosis, arterial disease and stroke.
In the present project we aim to study and highlight potential vascular changes in young Inflammatory Bowel Disease (IBD) patients and compare these changes with age and gender matched controls. Vasculature will be measured in multiple ways including blood analysis in the laboratory and non-invasive, physiological measures of arterial health (e.g. ultrasound arterial scan). Our overall goal is to identify biomarkers indicative of increased risk of vascular dysfunction as this will open new avenues for early therapeutic intervention.
|Condition or disease|
|Inflammatory Bowel Disease Crohn Disease Ulcerative Colitis|
|Study Type :||Observational|
|Actual Enrollment :||63 participants|
|Official Title:||Investigation of Vascular Endothelial Dysfunction, Thromboembolism and Structural Arterial Disease in Paediatric and Adolescent Inflammatory Bowel Disease (IBD)|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||January 2017|
Age/sex matched control participants, not suffering from inflammatory bowel disease or any other chronic inflammatory disease
Inflammatory Bowel Disease
Patients with active or remissive inflammatory bowel disease
- Carotid-Femoral Pulse Wave Velocity (PWV) [ Time Frame: Once, upon recruitment ]Pulse wave velocity is a measure of arterial stiffness, and correlates with cardiovascular events and all-cause mortality.
- Plasma Microparticle (MP) number [ Time Frame: Once, upon recruitment ]Plasma microparticles will be isolated and enumerated by flow cytometry
- Carotid Intima Media Thickness [ Time Frame: Once, upon recruitment ]The thickness of the carotid tunica intima and tunica media will be assessed by ultrasound. This thickness correlates with atherosclerosis.
- Plasma Microparticle (MP) pro-thrombotic potential [ Time Frame: Once, upon recruitment ]Plasma microparticles will be isolated and their pro-thrombotic potential will be assessed by calibrated automated thrombogram (CAT).
- Circulating endothelial cells (CEC)s enumeration [ Time Frame: Once, upon recruitment ]Circulating endothelial cells enumerated from whole blood, as a marker for endothelial dysfunction.
- Plasma C-reactive protein (CRP) level [ Time Frame: Once, upon recruitment ]
- Plasma serum amyloid A (SAA) level [ Time Frame: Once, upon recruitment ]
- Plasma Tumour Necrosis Factor Alpha (TNF-a) level [ Time Frame: Once, upon recruitment ]
- Plasma interleukin 1 alpha (IL-1a) level [ Time Frame: Once, upon recruitment ]
- Plasma interleukin 1 beta (IL-1b) level [ Time Frame: Once, upon recruitment ]
- Plasma interleukin 6 (IL-6) level [ Time Frame: Once, upon recruitment ]
- Plasma Monocyte Chemotactic Protein 1 (MCP-1) level [ Time Frame: Once, upon recruitment ]
- Plasma Vascular Endothelial Growth Factor (VEGF) level [ Time Frame: Once, upon recruitment ]
- Plasma fasting lipid levels [ Time Frame: Once, upon recruitment ]
- Plasma angiopoietin 1/2 levels [ Time Frame: Once, upon recruitment ]
- Erythrocyte Sedimentation Rate [ Time Frame: Once, upon recruitment ]
- Plasma D-dimer level [ Time Frame: Once, upon recruitment ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161640
|Great Ormond Street Hospital|
|London, United Kingdom, WC1N 3JH|
|Principal Investigator:||James Bonner, BSc||University College, London|