Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

January 24, 2012 updated by: Joel Faintuch, University of Sao Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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;

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult males and females submitted to elective curative operations will be enrolled

Description

Inclusion Criteria:

  • Follow-up period > 3 years,
  • weight stable in the last year

Exclusion Criteria:

  • Reoperation or take-down of original operation,
  • consumptive diseases,
  • protein-calorie malnutrition,
  • organ failures,
  • pancreatic surgery,
  • cell or organ transplantation,
  • type 1 diabetes,
  • cognitive impairment or Alzheimer disease,
  • refusal to participate in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer gastrectomy
Patients previously submitted to partial/total gastrectomy for gastric cancer
Other: Interview, questionnaire, updated biochemical tests
Patients 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.
Colorectal cancer operation
Patients previously submitted to right colectomy or rectosignoidectomy for cancer
Other: Interview, questionnaire, updated biochemical tests
Patients 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.
Bariatric patients
Morbidly obese participants who underwent antiobesity Roux-en-Y gastric bypass
Other: Interview, questionnaire, updated biochemical tests
Patients 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose
Time Frame: 3-12 years change
Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association
3-12 years change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 3-12 years
Same as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.
3-12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Joel Faintuch, MD, PhD, Hospital das Clinicas, Sao Paulo, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 25, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lessdiabetes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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