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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
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
Control
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Plasma Microparticle (MP) number [ Time Frame: Once, upon recruitment ]
    Plasma microparticles will be isolated and enumerated by flow cytometry

  2. 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.

  3. 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).

  4. Circulating endothelial cells (CEC)s enumeration [ Time Frame: Once, upon recruitment ]
    Circulating endothelial cells enumerated from whole blood, as a marker for endothelial dysfunction.

  5. Plasma C-reactive protein (CRP) level [ Time Frame: Once, upon recruitment ]
  6. Plasma serum amyloid A (SAA) level [ Time Frame: Once, upon recruitment ]
  7. Plasma Tumour Necrosis Factor Alpha (TNF-a) level [ Time Frame: Once, upon recruitment ]
  8. Plasma interleukin 1 alpha (IL-1a) level [ Time Frame: Once, upon recruitment ]
  9. Plasma interleukin 1 beta (IL-1b) level [ Time Frame: Once, upon recruitment ]
  10. Plasma interleukin 6 (IL-6) level [ Time Frame: Once, upon recruitment ]
  11. Plasma Monocyte Chemotactic Protein 1 (MCP-1) level [ Time Frame: Once, upon recruitment ]
  12. Plasma Vascular Endothelial Growth Factor (VEGF) level [ Time Frame: Once, upon recruitment ]
  13. Plasma fasting lipid levels [ Time Frame: Once, upon recruitment ]
  14. Plasma angiopoietin 1/2 levels [ Time Frame: Once, upon recruitment ]
  15. Erythrocyte Sedimentation Rate [ Time Frame: Once, upon recruitment ]
  16. Plasma D-dimer level [ Time Frame: Once, upon recruitment ]

Biospecimen Retention:   Samples Without DNA
Platelet poor plasma (PPP)


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified by the Clinical Nurse Specialists (CNS's) for Inflammatory Bowel Disease (IBD), on-call Gastroenterology registrars and consultants as well as the Pre-admission Nurses (PAN) within Great Ormond Street Hospital (GOSH). The lead consultants for IBD would also alert us of suitable patients for the study, as well as any suitable patients attending their regular gastroenterology clinics.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Inflammatory bowel disease (IBD arm)
  • Aged between 8 years and 18 years at recruitment (both arms)

Exclusion Criteria:

  • Clinical diagnosis of Inflammatory Bowel Disease (Control arm)
  • Diagnosis of any other chronic inflammatory condition

Information from the National Library of Medicine

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


Locations
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United Kingdom
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: James Bonner, BSc University College, London
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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02161640    
Other Study ID Numbers: 13ID11
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases