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Anti TNF α Improves Endothelial Dysfunction in Crohns' Disease Patients

Phase 4
18 Years
40 Years
Open (Enrolling)
Crohn's Disease

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Trial Information

Anti TNF α Improves Endothelial Dysfunction in Crohns' Disease Patients

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

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

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

Inclusion Criteria:

- 20 Crohns patients with CDAI 150-450

- Non smoker

- No history of IHD

- Diabetes

- Obesity


- Vasculitis

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.


Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

In this study we will preformed an endothelial function test before and after 12 weeks of treatment, by Endopath device from Itamar medical, FDA approved. Endo-PAT tests can be carried out in both the office and hospital settings, with patients positioned either sitting or supine. Endo-PAT bio-sensors are placed on the index fingers of both arms. The test takes 15 minutes to complete, is very easy to perform, and is both operator and interpreter independent. Thermo-neutral, quiet surroundings are recommended. Endo-PAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff).

Outcome Time Frame:

12 month

Safety Issue:


Principal Investigator

Zittan Eran

Investigator Role:

Principal Investigator

Investigator Affiliation:



Israel: Ministry of Health

Study ID:




Start Date:

June 2013

Completion Date:

June 2018

Related Keywords:

  • Crohn's Disease
  • Crohn Disease