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Energy Metabolism in Patients With Short Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT02113228
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Julio Sergio Marchini, University of Sao Paulo

Brief 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.

Condition or disease
Short Bowel Syndrome

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Study Type : Observational
Actual Enrollment : 22 participants
Time Perspective: Prospective
Official Title: Assessment of Energy Metabolism in Patients With Short Bowel Syndrome Using the Doubly Labeled Water Method
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Group/Cohort
Short Bowel Syndrome
Verify the total energy expenditure in patients with short bowel syndrome using the doubly labeled water method.
Control Group
Verify the total energy expenditure in patients without short bowel syndrome using the doubly labeled water method.



Primary Outcome Measures :
  1. Assessment of total energy expenditure using the doubly labeled water method [ Time Frame: 14 days ]
    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.


Secondary Outcome Measures :
  1. Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively. [ Time Frame: After 12 hours of overnight fasting ]
    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).

  2. Physical activity assessment [ Time Frame: 14 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The recruitment of volunteers with short bowel syndrome (SIC) will be done in the Hospital das Clinicas, Faculty of Medicine of Ribeirão Preto, University of São Paulo (HCFMRP / USP). These individuals will be paired with volunteers without short bowel syndrome, which will be selected at the clinics of the Hospital of the Faculty of Medicine of Ribeirão Preto, and will constitute the control group.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113228


Locations
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Brazil
Clinical Hospital of Ribeirao Preto
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Julio S Marchini, PhD Ribeirão Preto Medical School. São Paulo University (USP)

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julio Sergio Marchini, Full Professor of Internal Medicine Department at Ribeirão Preto Medical School, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02113228     History of Changes
Other Study ID Numbers: Process HCRP: 1822/2013
CAAE: 12271713.3.0000.5440 ( Registry Identifier: Sistema Nacional de Informações sobre Ética em Pesquisa )
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Julio Sergio Marchini, University of Sao Paulo:
Energy metabolism
Stable isotopes
Short bowel syndrome
Doubly labeled water

Additional relevant MeSH terms:
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Syndrome
Short Bowel Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications