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

This study is currently recruiting participants.
Study NCT00488085.   Last updated on June 18, 2007.   Information provided by Tel-Aviv Sourasky Medical Center

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Descriptive Information Fields
Brief Title  Crohn’s Disease, Obesity and Disease Severity
Official Title  Crohn’s Disease, Obesity and Disease Severity
Brief Summary

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.

Detailed Description

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.

Study Phase
Study Type  Observational
Study Design  Cross-Sectional, Defined Population, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Crohn’s Disease, Obesity
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  June 2007
Completion Date December 2007
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
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    
Location Countries  Israel
Administrative Information Fields
NCT ID  NCT00488085
Organization ID TASMC-07-ID-173-CTIL
Secondary IDs ††
Study Sponsor  Tel-Aviv Sourasky Medical Center
Collaborators ††
Investigators 
Study Director:     Nachum Vaisman, Prof.     The Unit of Clinical Nutrition    
Information Provided By Tel-Aviv Sourasky Medical Center
Verification Date March 2007
First Received Date  June 17, 2007
Last Updated Date June 18, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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