Crohn DiseaseREECDNCT03054935
Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease
An observational study of Crohn Disease, run by Fabrizio Pasanisi at 1 site in Italy.
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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Indirect Calorimetry
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2016to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending Gastroenterology Unit
Who may be able to join
- Clinical diagnosis of Crohn's Disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Federico II University Hospital
Naples, 80131
Fabrizio Pasanisi, MD, PhD, +39 0817464747, pasanisi@unina.it
Iolanda Cioffi, PhD, +39 081 7462333, iolanda.cioffi@unina.it
About this study
Official title: The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study
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)
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Indirect Calorimetry
- Keywords
- Energy Expenditure, Body Composition, Food Intake
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryOther
Measurement of resting energy expenditure
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Indirect Calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (5)
Body composition assessment by bioelectrical impedence analysis (BIA)
Measured: At baseline
Assessment of muscle function by hand-grip strength
Hand-grip strength will be performed by dynamometer
Measured: At baseline
Food intake evaluation
Food intake will be assessed by filling 3 day food records
Measured: At baseline
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.
Measured: At baseline
Quality of Life (QoL)
Assessment of each patient's health and well-being using the short-form 36 (SF-36).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Jul 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fabrizio Pasanisi
- Sponsor type
- University, hospital or other
- Collaborators
- Fabiana Castiglione
- Responsible party
- Sponsor-investigator, Fabrizio Pasanisi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054935
- Sponsor's protocol ID
- 102/16
- Acronym
- REECD
- Status last verified
- May 2017
- First submitted
- 8 Feb 2017
- Last updated
- 9 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10705071Gong 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.
PubMed 24668997Kushner 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.
PubMed 1984342Rigaud 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.
PubMed 8125226Schneeweiss 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.
PubMed 10203559Vaisman 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.
PubMed 16928471
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03054935
- Acronym / sponsor ID
- REECD / 102/16
- Conditions
- Crohn Disease
- Keywords
- Energy Expenditure, Body Composition, Food Intake
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fabrizio PasanisiUniversity, hospital or other
- Collaborators
- Fabiana Castiglione
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject-CD | – | Other: Indirect CalorimetrySubjects with Crohn's Disease in active or quiescent phase, classified according to Crohn's Disease Activity Index (CDAI >150 active; CDAI < 150 quiescent) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending Gastroenterology Unit
Key inclusion criteria (1 listed)
- Clinical diagnosis of Crohn's Disease
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimetryMeasurement of resting energy expenditure | Other | Subject-CD |
Primary outcome
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.
5 secondary outcomes
Body composition assessment by bioelectrical impedence analysis (BIA)
Time frame: At baseline
Assessment of muscle function by hand-grip strength
Time frame: At baseline
Food intake evaluation
Time frame: At baseline
Inflammatory biomarkers
Time frame: At baseline
Quality of Life (QoL)
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 10705071Al-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.
- Background: PubMed 24668997Gong 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.
- Background: PubMed 1984342Kushner 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.
- Background: PubMed 8125226Rigaud 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.
- Background: PubMed 10203559Schneeweiss 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.
- Background: PubMed 16928471Vaisman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Fabrizio Pasanisi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Pasanisi, MD, PhD (+39 081 7464747, pasanisi@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054935, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.