Crohn's Disease, Obesity and Disease Severity

NCT ID: NCT00488085

Last Updated: 2007-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease, Obesity

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Nachum Vaisman, Prof.

Role: STUDY_DIRECTOR

The Unit of Clinical Nutrition

Locations

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The Unit of Clinical Nutrition

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Nachum Vaisman, Prof.

Role: CONTACT

+972-524-266-596

Iris Dotan, Dr.

Role: CONTACT

+972-524-266-607

Other Identifiers

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TASMC-07-ID-173-CTIL

Identifier Type: -

Identifier Source: org_study_id