Clinical Trials Directory

Trials / Completed

CompletedNCT01518023

Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Status
Completed
Phase
Study type
Observational
Enrollment
240 (actual)
Sponsor
University of Sao Paulo · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose and hemoglobin A1c concentration.

Detailed description

In a prospective protocol with retrospective information, patients (N=240) undergoing bariatric Roux-en-Y gastric bypass (n=80), cancer subtotal or total gastrectomy (n=80) and right colectomy or rectosigmoidectomy (n=80) with follow-up \>3 years free of disease, with or without previously impaired fasting blood glucose, will be recruited. Patients will be submitted to a questionnaire involving diet, diagnosis of diabetes and glucose-lowering drugs, body weight and other clinical items. Preoperative information available in the hospital system will be completed and current findings will be updated, including body mass index and biochemical measurements. Using the outcomes of the bariatric population as benchmark, both concerning diabetics that were ameliorated and nondiabetics that progressed to new-onset diabetes,results in the other groups will be compared. The study should answer whether gastric and colorectal surgery for cancer 1) Are beneficial for established diabetes; 2) Attenuate the conversion of normal patients to diabetes, both within a follow-up period of 3- 12 years;

Conditions

Interventions

TypeNameDescription
OTHERInterview, questionnaire, updated biochemical testsPatients will be interviewed and questioned about nutritional status, diet, drugs and diagnosis/clinical course of diabetes. Routine biochemical tests will be searched and if necessary updated.

Timeline

Start date
2011-01-01
Primary completion
2011-12-01
Completion
2011-12-01
First posted
2012-01-25
Last updated
2012-01-25

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01518023. Inclusion in this directory is not an endorsement.