Vascular Dysfunction in Paediatric IBD

NCT02161640 | Completed

• 1 other identifier: 13ID11
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Carotid-Femoral Pulse Wave Velocity (PWV)

  Pulse wave velocity is a measure of arterial stiffness, and correlates with cardiovascular events and all-cause mortality.

  Once, upon recruitment

Secondary Outcomes (16)

• Plasma Microparticle (MP) number

  Once, upon recruitment

• Carotid Intima Media Thickness

  Once, upon recruitment

• Plasma Microparticle (MP) pro-thrombotic potential

  Once, upon recruitment

• Circulating endothelial cells (CEC)s enumeration

  Once, upon recruitment

• Plasma C-reactive protein (CRP) level

  Once, upon recruitment

Study Arms (2)

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

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Great Ormond Street Hospital

London, London, WC1N 3JH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Platelet poor plasma (PPP)

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• James Bonner, BSc

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

GB (1)