Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- HbA1c [3-12 years]
Same as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Follow-up period > 3 years,
-
weight stable in the last year
Exclusion Criteria:
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Reoperation or take-down of original operation,
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consumptive diseases,
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protein-calorie malnutrition,
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organ failures,
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pancreatic surgery,
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cell or organ transplantation,
-
type 1 diabetes,
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cognitive impairment or Alzheimer disease,
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refusal to participate in the protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077 | Sao Paulo | Brazil | 05403-900 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Study Chair: Joel Faintuch, MD, PhD, Hospital das Clinicas, Sao Paulo, Brazil
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Lessdiabetes