The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease
Study Overview
Brief Summary
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)
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of Crohn's Disease
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Fabrizio Pasanisi
Associate Professor of Internal Medicine
Federico II University