Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2011

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;

Interventions

  • 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.

Arms, Groups and Cohorts

  • Cancer gastrectomy
    • Patients previously submitted to partial/total gastrectomy for gastric cancer
  • Colorectal cancer operation
    • Patients previously submitted to right colectomy or rectosignoidectomy for cancer
  • Bariatric patients
    • Morbidly obese participants who underwent antiobesity Roux-en-Y gastric bypass

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joel Faintuch, Associate Professor, Department of Gastroenterology – University of Sao Paulo
  • Overall Official(s)
    • Joel Faintuch, MD, PhD, Study Chair, Hospital das Clinicas, Sao Paulo, Brazil

References

Faintuch J, Yamaguchi CM, Dias MC, Santo MA, Faintuch JJ, Cecconello I. Biochemical correlates of bariatric-responsive diabetes. Diabetes Technol Ther. 2010 Sep;12(9):707-15. doi: 10.1089/dia.2010.0018.

Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49.

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