Energy Metabolism in Patients With Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

Official title:

Assessment of Energy Metabolism in Patients With Short Bowel Syndrome Using the Doubly Labeled Water Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113228
• Other study ID #: Process HCRP: 1822/2013
• Secondary ID: CAAE: 12271713.3
• Status: Completed
• Phase: N/A
• First received: April 10, 2014
• Last updated: December 2, 2014
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Ribeirao Preto	Ribeirão Preto	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

Araújo 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. Epub 2007 Sep 17. — View Citation

DiBaise JK, Young RJ, Vanderhoof JA. Intestinal rehabilitation and the short bowel syndrome: part 2. Am J Gastroenterol. 2004 Sep;99(9):1823-32. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Jeppesen PB, Mortensen PB. Intestinal failure defined by measurements of intestinal energy and wet weight absorption. Gut. 2000 May;46(5):701-6. Erratum in: Gut 2000 Jul;47(1):158. — View Citation

Schoeller DA, Taylor PB, Shay K. Analytic requirements for the doubly labeled water method. Obes Res. 1995 Mar;3 Suppl 1:15-20. Review. — View Citation

Schoeller DA. Measurement of energy expenditure in free-living humans by using doubly labeled water. J Nutr. 1988 Nov;118(11):1278-89. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of total energy expenditure using the doubly labeled water method	After the determination of resting energy expenditure (REE), each volunteer will receive a dose of doubly labeled water (2H2 18O). A basal urine sample is collected before the intake dose and samples taken on days 1, 2, 3, 7, 12, 13, 14, thereafter. Urine samples will be analyzed by mass spectrometry (Hydra System, HIP 20-20, Europa Scientific, Cheshire, UK) in the Mass Spectrometry Laboratory of the Faculty of Medicine of Ribeirão Preto.	14 days	No
Secondary	Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.	This study also aims to measure the REE by indirect calorimetry with a Quark (Cosmed, Italy) calorimeter and the body composition by Byodinamics 450 (Biodynamics Corp., United States).	After 12 hours of overnight fasting	No
Secondary	Physical activity assessment	An activity monitor (activPAL ®, Glasgow, UK) is used to determine physical activity. By registering the intensity and duration of each category of activities, the system adds the energy estimated to generate a value that reflects the total energy expenditure.	14 days	No

External Links

•   Website of the Clinical Hospital of the Ribeirão Preto Medical School.