Clinical trial NCT01224054: Food and Gastrointestinal Habits After Bariatric Surgery
Official title: Food Tolerance in Patients Submitted to Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgeries
Keywords: Tolerance alimentary
Morbid obesity
Type 2 Diabetes Mellitus
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 34
Sex: ALL
Minimum age (years): 24
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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

Eligibility criteria: Inclusion Criteria:

* Patients submitted of bypass gastric, biliopancreatic diversion and duodenal exclusion

Exclusion Criteria:

* Presenting no diseases that could compromise their nutritional status, such as liver disease, kidney or cancer.

Primary outcomes:
measure: Food tolerance in patients submitted to bariatric surgery
timeFrame: After 1 to 5 years of bariatric surgeries
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: LIMED - Laboratory of Investigation on Metabolism and Diabetes/Gastrocentro/University of Campinas (UNICAMP)
state: Sao Paulo
Study officials:
affiliation: University of Campinas (UNICAMP)
name: Bruno Geloneze
role: PRINCIPAL_INVESTIGATOR
affiliation: +55-19-3521-8589
name: Daniela Tezoto
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: Éliton Chaim
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: Marcelo Lima
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: Sylka Geloneze
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: José Carlos Pareja
role: STUDY_CHAIR
affiliation: Gama Filho University
name: Vanessa Coutinho
role: STUDY_CHAIR
References: