The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease
研究概览
简要总结
The aim of this study is to investigate the effect disease activity on resting energy expenditure (REE), body composition, inflammatory markers, food intake and quality of life in subjects affected by Crohn's Disease (CD)
详细描述
Malnutrition is a common sequel among patients affected by Crohn's disease (CD). The pathogenic mechanisms include poor dietary intake, increased resting energy expenditure (REE), nutrient malabsorption and loss. So far, few studies have been carried out in CD adult patients, assessing the effect of disease activity on both REE and body composition. Vaisman et al (2006) studied sixteen CD patients in remission (> 3 mo) and showed no effect of REE on lower BMI, although in the presence of similar energy intake in according with previous studies (Al-Jaouni et al., 2000; Schneeweiss et al., 1999). While, Gong et al., 2015 found that patients with active disease had an increase in REE compared to patients in remission as already shown by Rigaud et al., 1993; Kushner and Schoeller, 1991. Overall, the effect of disease activity on REE is still uncertain and requires further investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Crohn's Disease
排除标准
- •Comorbidity affecting energy metabolism (diabetes mellitus, thyroid dysfunction, etc.)
- •History of acute or chronic liver or kidney disease
- •Current parenteral nutrition
- •Presence of fistulae, ileostomy or colostomy
- •Presence of extensive small bowel resection (residual small bowel < 2 meters)
- •Pregnancy or lactation
结局指标
主要结局
Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease
时间窗: At baseline
The measurement of REE by IC is a non-invasive method that measures oxygen consumption and carbon dioxide production and it is generally considered the gold standard in clinical practice.
次要结局
- Body composition assessment by bioelectrical impedence analysis (BIA)(At baseline)
- Assessment of muscle function by hand-grip strength(At baseline)
- Food intake evaluation(At baseline)
- Inflammatory biomarkers(At baseline)
- Quality of Life (QoL)(At baseline)
研究者
Fabrizio Pasanisi
Associate Professor of Internal Medicine
Federico II University