Bariatric SurgeryNCT01231087
Energy Expenditure Pre and Post Bariatric Surgery
An observational study of Bariatric Surgery, run by Gastrocirurgia, Brazil at 1 site in Brazil.
Trial summary
Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass surgery). They are going to do also body composition analysis in both moments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bariatric Surgery
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Oct 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese petiets
Who may be able to join
- obese patients that will be submitted to bariatric procedure
Who cannot join
- patients that don´t have clinical conditions to be submitted to a bariatric procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Energy Expenditure in Patients Pre and Post Bariatric Surgery
Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass surgery). They are going to do also body composition analysis in both moments.
The investigators are going to compare the results to see if the bariatric surgery increases their energy expenditure.
- Conditions
- Bariatric Surgery
- Keywords
- energy expenditure, morbid obesity, bariatric surgery, nutritional follow-up
- Medical subject headings
- Obesity, Morbid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gastrocirurgia, Brazil
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231087
- Sponsor's protocol ID
- Gastrocirurgia
- Status last verified
- Oct 2010
- First submitted
- 29 Oct 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure in Patients Pre and Post Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01231087
- Acronym / sponsor ID
- Gastrocirurgia
- Conditions
- Bariatric Surgery
- Keywords
- energy expenditure, morbid obesity, bariatric surgery, nutritional follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gastrocirurgia, BrazilUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2008 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 1 Nov 2010 (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.
Obese patients are going to be submitted to indirect calorimetry pre-operatively and we are going to repeat the same exam 6 months after bariatric surgery (post Roux-en-Y gastric Bypass surgery). They are going to do also body composition analysis in both moments.
The investigators are going to compare the results to see if the bariatric surgery increases their energy expenditure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese petiets
Key inclusion criteria (1 listed)
- obese patients that will be submitted to bariatric procedure
Key exclusion criteria (1 listed)
- patients that don´t have clinical conditions to be submitted to a bariatric procedure
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
Not reported in the source record.
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 1 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bariatric Surgery, run by Gastrocirurgia, Brazil 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 1 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 1 Nov 2010. 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.
Where can I read the original study information?
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 1 Nov 2010.