Energy Metabolism in Patients With Short Bowel Syndrome

Completed

• Conditions: Short Bowel Syndrome

• Registration Number: NCT02113228
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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Exclusion Criteria

• Short bowel syndrome: time of bowel resection surgery less than 1 year.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of total energy expenditure using the doubly labeled water method	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

Name	Time	Method
Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.	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).
Physical activity assessment	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.

Trial Locations

Locations (1)

Clinical Hospital of Ribeirao Preto; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil