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Trial record 2 of 114 for:    Short Bowel Syndrome

Energy Metabolism in Patients With Short Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Julio Sergio Marchini, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02113228
First received: April 10, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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
Short Bowel Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Energy Metabolism in Patients With Short Bowel Syndrome Using the Doubly Labeled Water Method

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 22
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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02113228

Contacts
Contact: Priscila G Fassini, MSc. +55 16 36023375 priscilafassini@usp.br
Contact: Karina Pfrimer, Dr. +55 16 36023370 kpfrimer@fmrp.usp.br

Locations
Brazil
Clinical Hospital of Ribeirao Preto Recruiting
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Contact: Priscila G Fassini, MSc    +55 16 36023375    priscilafassini@usp.br   
Contact: Karina Pfrimer, Dra.    +55 16 36023370    kpfrimer@fmrp.usp.br   
Sub-Investigator: Priscila G Fassini, MSc.         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Julio S Marchini, PhD Ribeirão Preto Medical School. São Paulo University (USP)
  More Information

Additional Information:
Publications:

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
Study First Received: April 10, 2014
Last Updated: April 10, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on November 23, 2014