Crohn’s Disease, Obesity and Disease Severity (CROHN_OBESE)
Recruitment status was Recruiting
|First Received Date ICMJE||June 17, 2007|
|Last Updated Date||June 18, 2007|
|Start Date ICMJE||June 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00488085 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Crohn’s Disease, Obesity and Disease Severity|
|Official Title ICMJE||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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Time Perspective: Cross-Sectional
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Crohn’s Disease, Obesity|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||40|
|Estimated Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Israel|
|NCT Number ICMJE||NCT00488085|
|Other Study ID Numbers ICMJE||TASMC-07-ID-173-CTIL|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Tel-Aviv Sourasky Medical Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Tel-Aviv Sourasky Medical Center|
|Verification Date||March 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP