NCT03054935

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

February 8, 2017

Last Update Submit

May 8, 2017

Conditions

Crohn Disease

Keywords

Energy ExpenditureBody CompositionFood Intake

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

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)

Other: Indirect Calorimetry

Interventions

Indirect CalorimetryOTHER

Measurement of resting energy expenditure

Subject-CD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients attending Gastroenterology Unit

You may qualify if:

  • Clinical diagnosis of Crohn's Disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University Hospital

Napoli, 80131, Italy

RECRUITING

Related Publications (6)

  • 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.

    PMID: 10705071BACKGROUND

  • 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.

    PMID: 24668997BACKGROUND

  • 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.

    PMID: 1984342BACKGROUND

  • 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.

    PMID: 8125226BACKGROUND

  • 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.

    PMID: 10203559BACKGROUND

  • 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.

    PMID: 16928471BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

CalorimetryChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Fabrizio Pasanisi, MD, PhD

CONTACT

+39 081 7464747pasanisi@unina.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 16, 2017

Study Start

July 1, 2016

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

IT(1)