Energy Metabolism in Patients With Short Bowel Syndrome
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.
Short Bowel Syndrome
|Study Design:||Time Perspective: Prospective|
|Official Title:||Assessment of Energy Metabolism in Patients With Short Bowel Syndrome Using the Doubly Labeled Water Method|
- Assessment of total energy expenditure using the doubly labeled water method [ Time Frame: 14 days ] [ Designated as safety issue: No ]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.
- Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively. [ Time Frame: After 12 hours of overnight fasting ] [ Designated as safety issue: No ]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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Short Bowel Syndrome
Verify the total energy expenditure in patients with short bowel syndrome using the doubly labeled water method.
Verify the total energy expenditure in patients without short bowel syndrome using the doubly labeled water method.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02113228
|Contact: Priscila G Fassini, MSc.||+55 16 firstname.lastname@example.org|
|Contact: Karina Pfrimer, Dr.||+55 16 email@example.com|
|Clinical Hospital of Ribeirao Preto||Recruiting|
|Ribeirão Preto, Sao Paulo, Brazil, 14048-900|
|Contact: Priscila G Fassini, MSc +55 16 36023375 firstname.lastname@example.org|
|Contact: Karina Pfrimer, Dra. +55 16 36023370 email@example.com|
|Sub-Investigator: Priscila G Fassini, MSc.|
|Principal Investigator:||Julio S Marchini, PhD||Ribeirão Preto Medical School. São Paulo University (USP)|