Short Bowel SyndromeNCT02113228
Energy Metabolism in Patients With Short Bowel Syndrome
An observational study of Short Bowel Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Short Bowel Syndrome
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Short bowel syndrome: time of bowel resection surgery less than 1 year.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Ribeirao Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Assessment of Energy Metabolism in Patients With Short Bowel Syndrome Using the Doubly Labeled Water Method
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.
- Conditions
- Short Bowel Syndrome
- Keywords
- Energy metabolism, Stable isotopes, Short bowel syndrome, Doubly labeled water
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of total energy expenditure using the doubly labeled water method
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.
Measured: 14 days
Secondary outcomes (2)
Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.
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).
Measured: After 12 hours of overnight fasting
Physical activity assessment
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Julio Sergio Marchini, University of Sao Paulo
- Investigators
- Julio S Marchini, PhD, Principal investigator, Ribeirão Preto Medical School. São Paulo University (USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113228
- Sponsor's protocol ID
- Process HCRP: 1822/2013
- Other IDs
- CAAE: 12271713.3.0000.5440
- Status last verified
- Dec 2014
- First submitted
- 10 Apr 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schoeller DA, Taylor PB, Shay K. Analytic requirements for the doubly labeled water method. Obes Res. 1995 Mar;3 Suppl 1:15-20. doi: 10.1002/j.1550-8528.1995.tb00003.x.
PubMed 7736285Frayn KN. Calculation of substrate oxidation rates in vivo from gaseous exchange. J Appl Physiol Respir Environ Exerc Physiol. 1983 Aug;55(2):628-34. doi: 10.1152/jappl.1983.55.2.628.
PubMed 6618956Ferreira IM, Braga CB, Dewulf Nde L, Marchini JS, da Cunha SF. Vitamin serum level variations between cycles of intermittent parenteral nutrition in adult patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):75-80. doi: 10.1177/0148607112441800. Epub 2012 Mar 27.
PubMed 22457422Thomson AB, Chopra A, Clandinin MT, Freeman H. Recent advances in small bowel diseases: Part II. World J Gastroenterol. 2012 Jul 14;18(26):3353-74. doi: 10.3748/wjg.v18.i26.3353.
PubMed 22807605DiBaise JK, Young RJ, Vanderhoof JA. Intestinal rehabilitation and the short bowel syndrome: part 2. Am J Gastroenterol. 2004 Sep;99(9):1823-32. doi: 10.1111/j.1572-0241.2004.40836.x.
PubMed 15330926Araujo EC, Suen VM, Marchini JS, Vannucchi H. Ideal weight better predicts resting energy expenditure than does actual weight in patients with short bowel syndrome. Nutrition. 2007 Nov-Dec;23(11-12):778-81. doi: 10.1016/j.nut.2007.07.007. Epub 2007 Sep 17.
PubMed 17869483Donohoe CL, Reynolds JV. Short bowel syndrome. Surgeon. 2010 Oct;8(5):270-9. doi: 10.1016/j.surge.2010.06.004.
PubMed 20709285Ferriolli E, Pfrimer K, Moriguti JC, Lima NK, Moriguti EK, Formighieri PF, Scagliusi FB, Marchini JS. Under-reporting of food intake is frequent among Brazilian free-living older persons: a doubly labelled water study. Rapid Commun Mass Spectrom. 2010 Mar 15;24(5):506-10. doi: 10.1002/rcm.4333.
PubMed 20112270Jeppesen PB, Mortensen PB. Intestinal failure defined by measurements of intestinal energy and wet weight absorption. Gut. 2000 May;46(5):701-6. doi: 10.1136/gut.46.5.701.
PubMed 10764715Schoeller DA. Measurement of energy expenditure in free-living humans by using doubly labeled water. J Nutr. 1988 Nov;118(11):1278-89. doi: 10.1093/jn/118.11.1278.
PubMed 3142975Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current management of short bowel syndrome. Curr Probl Surg. 2012 Feb;49(2):52-115. doi: 10.1067/j.cpsurg.2011.10.002. No abstract available.
PubMed 22244264Fassini PG, Das SK, Pfrimer K, Suen VMM, Sergio Marchini J, Ferriolli E. Energy intake in short bowel syndrome: assessment by 24-h dietary recalls compared with the doubly labelled water method. Br J Nutr. 2018 Jan;119(2):196-201. doi: 10.1017/S0007114517003373. Epub 2017 Dec 22.
PubMed 29268807Fassini PG, Nicoletti CF, Pfrimer K, Nonino CB, Marchini JS, Ferriolli E. Bioelectrical impedance vector analysis as a useful predictor of nutritional status in patients with short bowel syndrome. Clin Nutr. 2017 Aug;36(4):1117-1121. doi: 10.1016/j.clnu.2016.07.011. Epub 2016 Jul 27.
PubMed 27491548Fassini PG, Pfrimer K, Ferriolli E, Suen VM, Marchini JS, Das SK. Assessment of energy requirements in patients with short bowel syndrome by using the doubly labeled water method. Am J Clin Nutr. 2016 Jan;103(1):77-82. doi: 10.3945/ajcn.115.122408. Epub 2015 Dec 16.
PubMed 26675764
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Energy Metabolism in Patients With Short Bowel Syndrome Using the Doubly Labeled Water Method
- ClinicalTrials.gov ID
- NCT02113228
- Acronym / sponsor ID
- Process HCRP: 1822/2013
- Conditions
- Short Bowel Syndrome
- Keywords
- Energy metabolism, Stable isotopes, Short bowel syndrome, Doubly labeled water
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Short bowel syndrome: time of bowel resection surgery less than 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.
Time frame: After 12 hours of overnight fasting
Physical activity assessment
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 7736285Schoeller DA, Taylor PB, Shay K. Analytic requirements for the doubly labeled water method. Obes Res. 1995 Mar;3 Suppl 1:15-20. doi: 10.1002/j.1550-8528.1995.tb00003.x.
- Background: PubMed 6618956Frayn KN. Calculation of substrate oxidation rates in vivo from gaseous exchange. J Appl Physiol Respir Environ Exerc Physiol. 1983 Aug;55(2):628-34. doi: 10.1152/jappl.1983.55.2.628.
- Background: PubMed 22457422Ferreira IM, Braga CB, Dewulf Nde L, Marchini JS, da Cunha SF. Vitamin serum level variations between cycles of intermittent parenteral nutrition in adult patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):75-80. doi: 10.1177/0148607112441800. Epub 2012 Mar 27.
- Background: PubMed 22807605Thomson AB, Chopra A, Clandinin MT, Freeman H. Recent advances in small bowel diseases: Part II. World J Gastroenterol. 2012 Jul 14;18(26):3353-74. doi: 10.3748/wjg.v18.i26.3353.
- Background: PubMed 15330926DiBaise JK, Young RJ, Vanderhoof JA. Intestinal rehabilitation and the short bowel syndrome: part 2. Am J Gastroenterol. 2004 Sep;99(9):1823-32. doi: 10.1111/j.1572-0241.2004.40836.x.
- Background: PubMed 17869483Araujo EC, Suen VM, Marchini JS, Vannucchi H. Ideal weight better predicts resting energy expenditure than does actual weight in patients with short bowel syndrome. Nutrition. 2007 Nov-Dec;23(11-12):778-81. doi: 10.1016/j.nut.2007.07.007. Epub 2007 Sep 17.
- Background: PubMed 20709285Donohoe CL, Reynolds JV. Short bowel syndrome. Surgeon. 2010 Oct;8(5):270-9. doi: 10.1016/j.surge.2010.06.004.
- Background: PubMed 20112270Ferriolli E, Pfrimer K, Moriguti JC, Lima NK, Moriguti EK, Formighieri PF, Scagliusi FB, Marchini JS. Under-reporting of food intake is frequent among Brazilian free-living older persons: a doubly labelled water study. Rapid Commun Mass Spectrom. 2010 Mar 15;24(5):506-10. doi: 10.1002/rcm.4333.
- Background: PubMed 10764715Jeppesen PB, Mortensen PB. Intestinal failure defined by measurements of intestinal energy and wet weight absorption. Gut. 2000 May;46(5):701-6. doi: 10.1136/gut.46.5.701.
- Background: PubMed 3142975Schoeller DA. Measurement of energy expenditure in free-living humans by using doubly labeled water. J Nutr. 1988 Nov;118(11):1278-89. doi: 10.1093/jn/118.11.1278.
- Background: PubMed 22244264Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current management of short bowel syndrome. Curr Probl Surg. 2012 Feb;49(2):52-115. doi: 10.1067/j.cpsurg.2011.10.002. No abstract available.
- Derived from this study: PubMed 29268807Fassini PG, Das SK, Pfrimer K, Suen VMM, Sergio Marchini J, Ferriolli E. Energy intake in short bowel syndrome: assessment by 24-h dietary recalls compared with the doubly labelled water method. Br J Nutr. 2018 Jan;119(2):196-201. doi: 10.1017/S0007114517003373. Epub 2017 Dec 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio S Marchini, PhD principal investigator
Ribeirão Preto Medical School. São Paulo University (USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Bowel Syndrome, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of total energy expenditure using the doubly labeled water method (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113228, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.