Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease

NCT ID: NCT03054935

Last Updated: 2017-05-09

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Crohn Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subject-CD

Subjects with Crohn's Disease in active or quiescent phase, classified according to Crohn's Disease Activity Index (CDAI \>150 active; CDAI \< 150 quiescent)

Indirect Calorimetry

Intervention Type OTHER

Measurement of resting energy expenditure

Interventions

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Indirect Calorimetry

Measurement of resting energy expenditure

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fabiana Castiglione

UNKNOWN

Sponsor Role collaborator

Fabrizio Pasanisi

OTHER

Sponsor Role lead

Responsible Party

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Fabrizio Pasanisi

Associate Professor of Internal Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Federico II University Hospital

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fabrizio Pasanisi, MD, PhD

Role: CONTACT

+39 081 7464747

Facility Contacts

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Fabrizio Pasanisi, MD, PhD

Role: primary

+39 0817464747

Iolanda Cioffi, PhD

Role: backup

+39 081 7462333

References

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Al-Jaouni R, Hebuterne X, Pouget I, Rampal P. Energy metabolism and substrate oxidation in patients with Crohn's disease. Nutrition. 2000 Mar;16(3):173-8. doi: 10.1016/s0899-9007(99)00281-6.

Reference Type BACKGROUND
PMID: 10705071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24668997 (View on PubMed)

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. doi: 10.1093/ajcn/53.1.161.

Reference Type BACKGROUND
PMID: 1984342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8125226 (View on PubMed)

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. doi: 10.1093/jn/129.4.844.

Reference Type BACKGROUND
PMID: 10203559 (View on PubMed)

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. doi: 10.1016/j.nut.2006.05.013.

Reference Type BACKGROUND
PMID: 16928471 (View on PubMed)

Other Identifiers

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102/16

Identifier Type: -

Identifier Source: org_study_id

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