Bariatric SurgeriesNCT01224054
Food and Gastrointestinal Habits After Bariatric Surgery
An observational study of Bariatric Surgeries, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The worldwide epidemic of overweight and obesity affects about 1.7 billion people around the world. Since 1991, many international medical societies have established as recommendation for bariatric surgery the unsuccessful clinical treatment in patients with IMC > 40Kg/m2 or IMC > 35Kg/m2 in the cases with serious… Read more about this study
- Who is it for?
- Ages 24 to 62 years
- Conditions the study is for
- Bariatric Surgeries
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Aug 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 24 to 62 years
- All sexes
- No healthy volunteers
- Adult
Study population: It was studied 34 patients (15 males, 19 female), ranging from 24 to 62 years old, who underwent bariatric surgery: gastric bypass (n=15), biliopancreatic diversion (n=9) or metabolic surgery: duodenal exclusion (n=10) with more than six months of follow-up postoperatively.
Who may be able to join
- Patients submitted of bypass gastric, biliopancreatic diversion and duodenal exclusion
Who cannot join
- Presenting no diseases that could compromise their nutritional status, such as liver disease, kidney or cancer.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LIMED - Laboratory of Investigation on Metabolism and Diabetes/Gastrocentro/University of Campinas (UNICAMP)
Campinas, São Paulo
About this study
Official title: Food Tolerance in Patients Submitted to Bariatric Surgery
The worldwide epidemic of overweight and obesity affects about 1.7 billion people around the world. Since 1991, many international medical societies have established as recommendation for bariatric surgery the unsuccessful clinical treatment in patients with IMC > 40Kg/m2 or IMC > 35Kg/m2 in the cases with serious co-morbidities related to the possible reversion of them with the lose of weight due to the surgery. In front of the new anatomical condition from the gastrointestinal tract the patients present changes in food preferences and in the food intake, which include modifications in food choices, perception of hungry and satiety and in the tolerance to determinate food. These changes in food intake of the patients are observed mostly in the first year after the surgery an adaptive phase to a new condition.
Read the detailed description
After the new anatomical condition of the gastrointestinal tract, provided by bariatric surgery leads patients to experience changes in food intake and behavior. The aim of this study was to assess alimentary habits, food intolerances and gastrointestinal symptoms in patients who underwent bariatric and metabolic procedures: Roux-en-Y gastric bypass, biliopancreatic diversion and duodenal exclusion. We studied 34 patients of both sexes, from outpatient clinics in Surgery of Obesity and the Metabolic Surgery at University of Campinas. They were submitted to bypass gastric in Roux-en-Y (n=15), biliopancreatic diversion (n=9) and duodenal exclusion (n=10). Validated questionnaire for assessment of food tolerance was applied in patients with more than six months of follow-up after surgery addressing diet and gastrointestinal symptoms. The descriptive and comparative analyses were performed by analysis of variance and bivariate correlation. In patients who underwent to bypass gastric food intolerance was greats regarding to ingestion of rice (33%) and red meat (33%) in comparison to others groups. The flatulence and diarrhea were more prevalent in patients who underwent biliopancreatic diversion. The vomiting was more prevalent in patients who underwent gastric bypass. Each procedure presents peculiarities to the anatomical and functional changes that affect the food absorption. This may have negative effects on the nutritional status of patients and affect the quality of life. The nutritional therapy for each individual procedure may assist in the management of clinical concerns of operated patients
- Conditions
- Bariatric Surgeries
- Keywords
- Tolerance alimentary, Morbid obesity, Type 2 Diabetes Mellitus
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Bypass gastric | The mixed surgery which combine the gastric reduction with some degree of disabsorption | |
| Biliopancreatic diversion | The mal-absorptive surgery which reduce the intestinal absorption of food | |
| Duodenal exclusion | This surgery provides disabsortion by duodenal derivation maintaining an intact stomach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food tolerance in patients submitted to bariatric surgery
This study aims to assess habits and food intolerances and gastrointestinal symptoms in patients who underwent bariatric surgery: Roux-en-Y gastric bypass, biliopancreatic diversion and metabolic surgery: duodenal exclusion.
Measured: After 1 to 5 years of bariatric surgeries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeriesStudies 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
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Geloneze, Principal investigator, University of Campinas (UNICAMP)Daniela Tezoto, Study chair, +55-19-3521-8589Éliton Chaim, Study chair, University of Campinas (UNICAMP)Marcelo Lima, Study chair, University of Campinas (UNICAMP)Sylka Geloneze, Study chair, University of Campinas (UNICAMP)José Carlos Pareja, Study chair, University of Campinas (UNICAMP)Vanessa Coutinho, Study chair, Gama Filho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224054
- Sponsor's protocol ID
- LIMED0009
- Other IDs
- CEP 289/2008
- Status last verified
- Oct 2010
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Tolerance in Patients Submitted to Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01224054
- Acronym / sponsor ID
- LIMED0009
- Conditions
- Bariatric Surgeries
- Keywords
- Tolerance alimentary, Morbid obesity, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 Oct 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.
The worldwide epidemic of overweight and obesity affects about 1.7 billion people around the world. Since 1991, many international medical societies have established as recommendation for bariatric surgery the unsuccessful clinical treatment in patients with IMC > 40Kg/m2 or IMC > 35Kg/m2 in the cases with serious co-morbidities related to the possible reversion of them with the lose of weight due to the surgery. In front of the new anatomical condition from the gastrointestinal tract the patients present changes in food preferences and in the food intake, which include modifications in food choices, perception of hungry and satiety and in the tolerance to determinate food. These changes in food intake of the patients are observed mostly in the first year after the surgery an adaptive phase to a new condition.
Detailed description
After the new anatomical condition of the gastrointestinal tract, provided by bariatric surgery leads patients to experience changes in food intake and behavior. The aim of this study was to assess alimentary habits, food intolerances and gastrointestinal symptoms in patients who underwent bariatric and metabolic procedures: Roux-en-Y gastric bypass, biliopancreatic diversion and duodenal exclusion. We studied 34 patients of both sexes, from outpatient clinics in Surgery of Obesity and the Metabolic Surgery at University of Campinas. They were submitted to bypass gastric in Roux-en-Y (n=15), biliopancreatic diversion (n=9) and duodenal exclusion (n=10). Validated questionnaire for assessment of food tolerance was applied in patients with more than six months of follow-up after surgery addressing diet and gastrointestinal symptoms. The descriptive and comparative analyses were performed by analysis of variance and bivariate correlation. In patients who underwent to bypass gastric food intolerance was greats regarding to ingestion of rice (33%) and red meat (33%) in comparison to others groups. The flatulence and diarrhea were more prevalent in patients who underwent biliopancreatic diversion. The vomiting was more prevalent in patients who underwent gastric bypass. Each procedure presents peculiarities to the anatomical and functional changes that affect the food absorption. This may have negative effects on the nutritional status of patients and affect the quality of life. The nutritional therapy for each individual procedure may assist in the management of clinical concerns of operated patients
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bypass gastric | – | –The mixed surgery which combine the gastric reduction with some degree of disabsorption |
| Biliopancreatic diversion | – | –The mal-absorptive surgery which reduce the intestinal absorption of food |
| Duodenal exclusion | – | –This surgery provides disabsortion by duodenal derivation maintaining an intact stomach |
Who may qualify
- Ages
- 24 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- It was studied 34 patients (15 males, 19 female), ranging from 24 to 62 years old, who underwent bariatric surgery: gastric bypass (n=15), biliopancreatic diversion (n=9) or metabolic surgery: duodenal exclusion (n=10) with more than six months of follow-up postoperatively.
Key inclusion criteria (1 listed)
- Patients submitted of bypass gastric, biliopancreatic diversion and duodenal exclusion
Key exclusion criteria (1 listed)
- Presenting no diseases that could compromise their nutritional status, such as liver disease, kidney or cancer.
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
Food tolerance in patients submitted to bariatric surgery
Time frame: After 1 to 5 years of bariatric surgeries
This study aims to assess habits and food intolerances and gastrointestinal symptoms in patients who underwent bariatric surgery: Roux-en-Y gastric bypass, biliopancreatic diversion and metabolic surgery: duodenal exclusion.
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 19 Oct 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.
Bruno Geloneze principal investigator
University of Campinas (UNICAMP)
Daniela Tezoto study chair
+55-19-3521-8589
Éliton Chaim study chair
University of Campinas (UNICAMP)
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 Surgeries, run by University of Campinas, 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 19 Oct 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.
What does the primary outcome measure?
Food tolerance in patients submitted to bariatric surgery (time frame: After 1 to 5 years of bariatric surgeries). It is what the study was designed to measure, not a finding.
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 19 Oct 2010.