Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease

Crohn Disease Clinical Trial

— REECD  

Official title:

The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03054935
• Other study ID #: 102/16
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2017
• Last updated: May 8, 2017
• Start date: July 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2017
• Source: Federico II University
• Contact: Fabrizio Pasanisi, MD, PhD
• Phone: +39 081 7464747
• Email: pasanisi[@]unina.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• Indirect Calorimetry
Measurement of resting energy expenditure

Locations

Country	Name	City	State
Italy	Federico II University Hospital	Napoli

Sponsors (2)

Lead Sponsor	Collaborator
Fabrizio Pasanisi	Fabiana Castiglione

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Al-Jaouni R, Hébuterne X, Pouget I, Rampal P. Energy metabolism and substrate oxidation in patients with Crohn's disease. Nutrition. 2000 Mar;16(3):173-8. — View Citation

Gong J, Zuo L, Guo Z, Zhang L, Li Y, Gu L, Zhao J, Cao L, Zhu W, Li N, Li J. Impact of Disease Activity on Resting Energy Expenditure and Body Composition in Adult Crohn's Disease: A Prospective Longitudinal Assessment. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):713-8. doi: 10.1177/0148607114528360. Epub 2014 Mar 25. — View Citation

Kushner RF, Schoeller DA. Resting and total energy expenditure in patients with inflammatory bowel disease. Am J Clin Nutr. 1991 Jan;53(1):161-5. — View Citation

Rigaud D, Cerf M, Angel Alberto L, Sobhani I, Carduner MJ, Mignon M. [Increase of resting energy expenditure during flare-ups in Crohn disease]. Gastroenterol Clin Biol. 1993;17(12):932-7. French. — View Citation

Schneeweiss B, Lochs H, Zauner C, Fischer M, Wyatt J, Maier-Dobersberger T, Schneider B. Energy and substrate metabolism in patients with active Crohn's disease. J Nutr. 1999 Apr;129(4):844-8. — View Citation

Vaisman N, Dotan I, Halack A, Niv E. Malabsorption is a major contributor to underweight in Crohn's disease patients in remission. Nutrition. 2006 Sep;22(9):855-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease	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.	At baseline
Secondary	Body composition assessment by bioelectrical impedence analysis (BIA)		At baseline
Secondary	Assessment of muscle function by hand-grip strength	Hand-grip strength will be performed by dynamometer	At baseline
Secondary	Food intake evaluation	Food intake will be assessed by filling 3 day food records	At baseline
Secondary	Inflammatory biomarkers	Serum concentration of high sensitive C-reactive protein (hs-RCP) will be determined by immunoturbidimetric assay while tumor necrosis factor - alpha (TNF-alpha) and Interleukin 6 (IL-6) will be assessed by ELISA.	At baseline
Secondary	Quality of Life (QoL)	Assessment of each patient's health and well-being using the short-form 36 (SF-36).	At baseline