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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00488085
Recruitment Status : Unknown
Verified March 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : June 19, 2007
Last Update Posted : June 19, 2007
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
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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.

Condition or disease
Crohn's Disease, Obesity

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Defined Population
Time Perspective: Other
Official Title: Crohn's Disease, Obesity and Disease Severity
Study Start Date : June 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488085


Contacts
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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

Locations
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Israel
The Unit of Clinical Nutrition Recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Study Director: Nachum Vaisman, Prof. The Unit of Clinical Nutrition
More Information
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ClinicalTrials.gov Identifier: NCT00488085    
Other Study ID Numbers: TASMC-07-ID-173-CTIL
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: June 19, 2007
Last Verified: March 2007
Keywords provided by Tel-Aviv Sourasky Medical Center:
Crohn's disease, obesity, REE, body composition, fat absorption
Additional relevant MeSH terms:
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Crohn Disease
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases