Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Crohn’s Disease, Obesity and Disease Severity (CROHN_OBESE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00488085
First received: June 17, 2007
Last updated: June 18, 2007
Last verified: March 2007

June 17, 2007
June 18, 2007
June 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00488085 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Crohn’s Disease, Obesity and Disease Severity
Crohn’s Disease, Obesity and Disease Severity

The aim of our study is to suggest possible underlying mechanisms for the observed clinical differences in disease severity and behavior of overweight and obese patients with crohn's disease(BMI > 25 kg/m²)as compare to non-obese crohn's patients with a normal or low weight ( BMI ≤ 25) by measuring metabolic\nutritional variables and cytokine levels.

Crohn’s disease (CD) is a chronic intestinal disorder of unknown etiology that may involve any part of the gastrointestinal tract. The small bowel is involved in 70% of CD patients.

Undernutrition expressed in low body mass index (BMI) <18.5 kg/m², is a common presentation and has been reported in 65–75% of these patients. Possible pathogenic mechanisms include inadequate dietary intake ,increased energy expenditure, nutrient malabsorption and intestinal losses. We have studied recently these three important components of energy balance of underweight crohn’s patients and found that nutrient malabsorption may play a role.

Although the majority of crohn's disease patients are undernourished , some of them are surprisingly obese and their symptoms seem be more severe; Blain A et al. have reported recently that obesity in CD has been associated with more frequent anoperineal complications and a more marked disease activity. Hass J et al have found that overweight CD patients require earlier surgical intervention and perhaps more aggressive medical therapy. Notwithstanding, the characteristics of CD and possible underlying pathophysiological mechanisms in obese patients have not been studied yet.

Mesenteric hypertrophied fat commonly called “creeping fat is a common feature of crohn's disease and has been reported to correlate with ulceration, stricture formation and transmural inflammation. It is a matter of debate whether the development of creeping fat is a causative or secondary phenomenon ,but there is increasing body of evidence that suggest that mesenteric adipose tissue plays an active role in the pathogenesis of creeping fat and mesenteric inflammation by pro-inflammatory and anti-inflammatory adipocytokines.

Recently there is more recognition that adipose tissue is not a passive connective tissue merely storing fat but an activeendocrine organ which participates in numerous physiological and pathophysiological processes with variety of secretory products designated adipocytokines that regulate metabolic processes in an endocrine ,paracrine and autocrine manner Moreover, Obesity is increasingly being recognized as a risk factor for a number of gastrointestinal conditions as well as being characterized by a chronic, systemic low-grade state of inflammation per se. Biomarkers of inflammation, such as the leukocyte count, tumor necrosis factor-alpha (TNF-alpha), interleukin 6 (IL-6), and C-reactive protein, are increased in obesity and have been related to insulin resistance and the metabolic syndrome.

Observational
Observational Model: Defined Population
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Not Provided
Not Provided
Crohn’s Disease, Obesity
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2007
Not Provided

Inclusion criteria:

  1. Age > 18 years
  2. No other chronic diseases except obesity -related (NAFLD, NASH etc).
  3. Stable (LESS THAN 10% CHANGE) body weight during the 3 months preceding the study.

Exclusion criteria:

  1. Patients with internal fistulae (perianal disease allowed)
  2. Ileostomy or colostomy
  3. Pregnancy
Both
18 Years and older
No
Contact: Nachum Vaisman, Prof. +972-524-266-596 vaisman@tasmc.health.gov.il
Contact: Iris Dotan, Dr. +972-524-266-607 irisd@tasmc.health.gov.il
Israel
 
NCT00488085
TASMC-07-ID-173-CTIL
Yes
Not Provided
Tel-Aviv Sourasky Medical Center
Not Provided
Study Director: Nachum Vaisman, Prof. The Unit of Clinical Nutrition
Tel-Aviv Sourasky Medical Center
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP