Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
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Purpose
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 | Intervention |
|---|---|
|
Diabetes Mellitus Prediabetes Morbid Obesity Gastric Cancer Colorectal Cancer |
Other: Interview, questionnaire, updated biochemical tests |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy |
- Fasting blood glucose [ Time Frame: 3-12 years change ] [ Designated as safety issue: No ]Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association
- HbA1c [ Time Frame: 3-12 years ] [ Designated as safety issue: No ]Same as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.
| Enrollment: | 240 |
| Study Start Date: | January 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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;
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult males and females submitted to elective curative operations will be enrolled
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
Contacts and Locations| Brazil | |
| Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077 | |
| Sao Paulo, Brazil, 05403-900 | |
| Study Chair: | Joel Faintuch, MD, PhD | Hospital das Clinicas, Sao Paulo, Brazil |
More Information
Publications:
| Responsible Party: | Joel Faintuch, Associate Professor, Department of Gastroenterology, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01518023 History of Changes |
| Other Study ID Numbers: | Lessdiabetes |
| Study First Received: | January 20, 2012 |
| Last Updated: | January 24, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
diabetes mellitus prediabetes fasting blood glucose HbA1c |
Roux en Y gastric bypass Cancer gastrectomy Cancer colorectal surgery |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Diabetes Mellitus Stomach Neoplasms Obesity Obesity, Morbid Glucose Intolerance Prediabetic State Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Stomach Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Hyperglycemia |
ClinicalTrials.gov processed this record on May 22, 2013