Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488085
Status:
UNKNOWN
Last Update Posted:
2007-06-19
First Post:
2007-06-17
Brief Title:
Crohns Disease Obesity and Disease Severity
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Crohns Disease Obesity and Disease Severity
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CROHN_OBESE
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 crohns diseaseBMI 25 kgm²as compare to non-obese crohns patients with a normal or low weight BMI 25 by measuring metabolicnutritional variables and cytokine levels
Detailed Description:
Crohns 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 185 kgm² 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 crohns patients and found that nutrient malabsorption may play a role
Although the majority of crohns 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 crohns 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
Undernutrition expressed in low body mass index BMI 185 kgm² 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 crohns patients and found that nutrient malabsorption may play a role
Although the majority of crohns 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 crohns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None