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NCT Number: NCT02113228

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.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 14, 2014
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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