Energy Metabolism in Patients With Short Bowel Syndrome

NCT ID: NCT02113228

Last Updated: 2014-12-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study proposes to verify the total energy expenditure in patients with short bowel syndrome using the doubly labeled water method, as well as determining the rate of oxidation of nutrients, aiming to assist the management of nutritional therapy for these patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Short Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Short Bowel Syndrome

Verify the total energy expenditure in patients with short bowel syndrome using the doubly labeled water method.

No interventions assigned to this group

Control Group

Verify the total energy expenditure in patients without short bowel syndrome using the doubly labeled water method.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Short bowel syndrome: short bowel syndrome patients with gastrointestinal transit time less or equal 30 minutes.
* Control group: patients with the same gender, presenting age and chronic diseases similar with volunteers from the group with short bowel syndrome.

Exclusion Criteria

\- Short bowel syndrome: time of bowel resection surgery less than 1 year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julio Sergio Marchini

Full Professor of Internal Medicine Department at Ribeirão Preto Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julio S Marchini, PhD

Role: PRINCIPAL_INVESTIGATOR

Ribeirão Preto Medical School. São Paulo University (USP)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Schoeller DA, Taylor PB, Shay K. Analytic requirements for the doubly labeled water method. Obes Res. 1995 Mar;3 Suppl 1:15-20. doi: 10.1002/j.1550-8528.1995.tb00003.x.

Reference Type BACKGROUND
PMID: 7736285 (View on PubMed)

Frayn KN. Calculation of substrate oxidation rates in vivo from gaseous exchange. J Appl Physiol Respir Environ Exerc Physiol. 1983 Aug;55(2):628-34. doi: 10.1152/jappl.1983.55.2.628.

Reference Type BACKGROUND
PMID: 6618956 (View on PubMed)

Ferreira IM, Braga CB, Dewulf Nde L, Marchini JS, da Cunha SF. Vitamin serum level variations between cycles of intermittent parenteral nutrition in adult patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):75-80. doi: 10.1177/0148607112441800. Epub 2012 Mar 27.

Reference Type BACKGROUND
PMID: 22457422 (View on PubMed)

Thomson AB, Chopra A, Clandinin MT, Freeman H. Recent advances in small bowel diseases: Part II. World J Gastroenterol. 2012 Jul 14;18(26):3353-74. doi: 10.3748/wjg.v18.i26.3353.

Reference Type BACKGROUND
PMID: 22807605 (View on PubMed)

DiBaise JK, Young RJ, Vanderhoof JA. Intestinal rehabilitation and the short bowel syndrome: part 2. Am J Gastroenterol. 2004 Sep;99(9):1823-32. doi: 10.1111/j.1572-0241.2004.40836.x.

Reference Type BACKGROUND
PMID: 15330926 (View on PubMed)

Araujo EC, Suen VM, Marchini JS, Vannucchi H. Ideal weight better predicts resting energy expenditure than does actual weight in patients with short bowel syndrome. Nutrition. 2007 Nov-Dec;23(11-12):778-81. doi: 10.1016/j.nut.2007.07.007. Epub 2007 Sep 17.

Reference Type BACKGROUND
PMID: 17869483 (View on PubMed)

Donohoe CL, Reynolds JV. Short bowel syndrome. Surgeon. 2010 Oct;8(5):270-9. doi: 10.1016/j.surge.2010.06.004.

Reference Type BACKGROUND
PMID: 20709285 (View on PubMed)

Ferriolli E, Pfrimer K, Moriguti JC, Lima NK, Moriguti EK, Formighieri PF, Scagliusi FB, Marchini JS. Under-reporting of food intake is frequent among Brazilian free-living older persons: a doubly labelled water study. Rapid Commun Mass Spectrom. 2010 Mar 15;24(5):506-10. doi: 10.1002/rcm.4333.

Reference Type BACKGROUND
PMID: 20112270 (View on PubMed)

Jeppesen PB, Mortensen PB. Intestinal failure defined by measurements of intestinal energy and wet weight absorption. Gut. 2000 May;46(5):701-6. doi: 10.1136/gut.46.5.701.

Reference Type BACKGROUND
PMID: 10764715 (View on PubMed)

Schoeller DA. Measurement of energy expenditure in free-living humans by using doubly labeled water. J Nutr. 1988 Nov;118(11):1278-89. doi: 10.1093/jn/118.11.1278.

Reference Type BACKGROUND
PMID: 3142975 (View on PubMed)

Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current management of short bowel syndrome. Curr Probl Surg. 2012 Feb;49(2):52-115. doi: 10.1067/j.cpsurg.2011.10.002. No abstract available.

Reference Type BACKGROUND
PMID: 22244264 (View on PubMed)

Fassini PG, Das SK, Pfrimer K, Suen VMM, Sergio Marchini J, Ferriolli E. Energy intake in short bowel syndrome: assessment by 24-h dietary recalls compared with the doubly labelled water method. Br J Nutr. 2018 Jan;119(2):196-201. doi: 10.1017/S0007114517003373. Epub 2017 Dec 22.

Reference Type DERIVED
PMID: 29268807 (View on PubMed)

Fassini PG, Nicoletti CF, Pfrimer K, Nonino CB, Marchini JS, Ferriolli E. Bioelectrical impedance vector analysis as a useful predictor of nutritional status in patients with short bowel syndrome. Clin Nutr. 2017 Aug;36(4):1117-1121. doi: 10.1016/j.clnu.2016.07.011. Epub 2016 Jul 27.

Reference Type DERIVED
PMID: 27491548 (View on PubMed)

Fassini PG, Pfrimer K, Ferriolli E, Suen VM, Marchini JS, Das SK. Assessment of energy requirements in patients with short bowel syndrome by using the doubly labeled water method. Am J Clin Nutr. 2016 Jan;103(1):77-82. doi: 10.3945/ajcn.115.122408. Epub 2015 Dec 16.

Reference Type DERIVED
PMID: 26675764 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAAE: 12271713.3.0000.5440

Identifier Type: REGISTRY

Identifier Source: secondary_id

Process HCRP: 1822/2013

Identifier Type: -

Identifier Source: org_study_id