Food and Gastrointestinal Habits After Bariatric Surgery

Bariatric Surgeries Clinical Trial

Official title:

Food Tolerance in Patients Submitted to Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224054
• Other study ID #: LIMED0009
• Secondary ID: CEP 289/2008
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 18, 2010
• Start date: July 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 62 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Bariatric Surgeries

Locations

Country	Name	City	State
Brazil	LIMED - Laboratory of Investigation on Metabolism and Diabetes/Gastrocentro/University of Campinas (UNICAMP)	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 1 to 5 years of bariatric surgeries	Yes