Food and Gastrointestinal Habits After Bariatric Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01224054
First received: October 18, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition
Bariatric Surgeries

Study Type: Observational
Official Title: Food Tolerance in Patients Submitted to Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Food tolerance in patients submitted to bariatric surgery [ Time Frame: After 1 to 5 years of bariatric surgeries ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 34
Study Start Date: July 2008
Study Completion Date: August 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   24 Years to 62 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224054

Locations
Brazil
LIMED - Laboratory of Investigation on Metabolism and Diabetes/Gastrocentro/University of Campinas (UNICAMP)
Campinas, Sao Paulo, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Bruno Geloneze University of Campinas (UNICAMP)
Study Chair: Daniela Tezoto +55-19-3521-8589
Study Chair: Éliton Chaim University of Campinas (UNICAMP)
Study Chair: Marcelo Lima University of Campinas (UNICAMP)
Study Chair: Sylka Geloneze University of Campinas (UNICAMP)
Study Chair: José Carlos Pareja University of Campinas (UNICAMP)
Study Chair: Vanessa Coutinho Gama Filho University
  More Information

No publications provided

Responsible Party: Bruno Geloneze, University of Campinas, Brazil (UNICAMP)
ClinicalTrials.gov Identifier: NCT01224054     History of Changes
Other Study ID Numbers: LIMED0009, CEP 289/2008
Study First Received: October 18, 2010
Last Updated: October 18, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
Tolerance alimentary
Morbid obesity
Type 2 Diabetes Mellitus

ClinicalTrials.gov processed this record on October 21, 2014