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Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03054935
Acronym
REECD
Enrollment
150
Registered
2017-02-16
Start date
2016-07-01
Completion date
2018-06-30
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Energy Expenditure, Body Composition, Food Intake

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.

Interventions

OTHERIndirect Calorimetry

Measurement of resting energy expenditure

Sponsors

Fabiana Castiglione
CollaboratorUNKNOWN
Fabrizio Pasanisi
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's DiseaseAt baselineThe 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

MeasureTime frameDescription
Body composition assessment by bioelectrical impedence analysis (BIA)At baseline
Assessment of muscle function by hand-grip strengthAt baselineHand-grip strength will be performed by dynamometer
Food intake evaluationAt baselineFood intake will be assessed by filling 3 day food records
Inflammatory biomarkersAt baselineSerum 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.
Quality of Life (QoL)At baselineAssessment of each patient's health and well-being using the short-form 36 (SF-36).

Countries

Italy

Contacts

Primary ContactFabrizio Pasanisi, MD, PhD
pasanisi@unina.it+39 081 7464747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026