Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Completed

• Conditions: Colorectal Cancer; Diabetes Mellitus; Prediabetes; Morbid Obesity; Gastric Cancer
• Interventions: Other: Interview, questionnaire, updated biochemical tests

• Registration Number: NCT01518023
• Lead Sponsor: University of Sao Paulo

Brief 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;

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-24
• Last Update Submitted: 2012-01-24
• Study First Posted: 2012-01-25
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose	3-12 years change	Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077; 🇧🇷 Sao Paulo, Brazil