Anti TNF α Improves Endothelial Dysfunction in IBD Patients

NCT ID: NCT01881464

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-06-30

Brief Summary

Study hypothesis - this study will assess the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.

Detailed Description

Crohn's Disease (CD) is a life long disease that mainly affects young adults. There is evidence That gut tissue injury is the result of an abnormal immune response that involved multiple non immune cellular systems including the intestinal microvascular endothelial cell. Moreover, clinical studies have shown that 1-7% of irritable bowel disease (IBD) patients suffer from arterial and venous thromboembolic complication.

Chronic inflammation has a major role in the development and propagation of endothelial dysfunction, which can lead to coronary artery disease.

Endothelial dysfunction has been described in patients with various and diverse chronic inflammatory conditions. Over the last few years, dysfunction of vascular endothelium has been widely recognized as the first step in the development of atherosclerosis. Several inflammatory mediators, such as C-reactive protein (CRP), Tumor Necrosis Factor α, (TNF α), nitric oxide (NO), vascular endothelial growth factor, CD-40, interleukin-6 (IL-6), which are up-regulated in IBD, also are known to impact vascular impact.

The normal endothelium produces a vasodilatatory response to ischemia referred to us as reactive hyperemia. Shear stress on the blood vessel wall leads to the production and release vasodilatation. With endothelial dysfunction there is often either a blunted vasodilatatory in response to ischemic event, and chronic inflammation.

The hypothesis of this study is that patients with Crohn's disease have an increased incidence of endothelial dysfunction, which can be corrected or improved by treatment with anti TNF α.

The purpose of our study was to assess endothelial function in patients with Crohn's Disease, before and after treatment (steroids, immunomodulators, and anti TNF α). This study assessed the presence of endothelial dysfunction in patients with Crohn's disease and evaluated the possible role of tumor necrosis factor (TNF)-α in the pathophysiology of this abnormality.

In this study we will preformed an endothelial function test before and after treatment by Endopath device from Itamar medical, FDA approved.

Safety- Each subject will be screened by clinical history, physical examination, electrocardiogram, chest X-ray, Mantoux test (PPD), routine chemical analysis, and biomarkers.

The study protocol has been approved by the local institutional review board.

Conditions

Crohn's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

endothelial dysfunction assessment

This study is a one arm study . In this arm we will assess endothelial function (with Endopath device) in patients with Crohn's disease, before and after treatment of anti TNF α and other medication, and evaluate the possible role of tumor necrosis factor (TNF)-α in the pathophysiology of this abnormality.

Endopath from Itamar medical - FDA approved device.

Intervention Type: DEVICE

endothelial function assessment by Endopath device

Anti TNF Alfa.

Intervention Type: DRUG

This study will assessed the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.

Interventions

Endopath from Itamar medical - FDA approved device.

endothelial function assessment by Endopath device

Intervention Type: DEVICE

Anti TNF Alfa.

This study will assessed the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.

Intervention Type: DRUG

Other Intervention Names

HUMIRA-ADALIMUMAB, REMICADE-INFLIXIMAB

Eligibility Criteria

Inclusion Criteria

• Non smoker
• No history of IHD or other known risk factors for IHD

Exclusion Criteria

• Patients who had been treated with anti TNF α 4 weeks before the study
• As well as those who received corticosteroids within 1 week before the study.
• DM, IHD, CRF, SMOKER

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zittan Eran

Role: PRINCIPAL_INVESTIGATOR

CARMEL MEDICAL CENTER - HAIFA -ISRAEL

Locations

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

zittan Eran, M.D

Role: CONTACT

eranzittan@gmail.com

972-48250359

Segol Ori, M.D

Role: CONTACT

Ori_Segol@clalit.org.il

972-4-8250359

Other Identifiers

CMC-13-0006-CTIL

Identifier Type: -

Identifier Source: org_study_id