Food and Gastrointestinal Habits After Bariatric Surgery

NCT01224054 | Completed

• 2 other identifiers: LIMED0009CEP 289/2008
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgeries

Keywords

Tolerance alimentary; Morbid obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 24 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

LIMED - Laboratory of Investigation on Metabolism and Diabetes/Gastrocentro/University of Campinas (UNICAMP)

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bruno Geloneze

  University of Campinas (UNICAMP)

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

BR (1)