Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

NCT ID: NCT01518023

Last Updated: 2012-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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;

Conditions

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Diabetes Mellitus Prediabetes Morbid Obesity Gastric Cancer Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer gastrectomy

Patients previously submitted to partial/total gastrectomy for gastric cancer

Interview, questionnaire, updated biochemical tests

Intervention Type OTHER

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

Interview, questionnaire, updated biochemical tests

Intervention Type OTHER

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

Interview, questionnaire, updated biochemical tests

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Joel Faintuch

Associate Professor, Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel Faintuch, MD, PhD

Role: STUDY_CHAIR

Hospital das Clinicas, Sao Paulo, Brazil

Locations

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Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 20707737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22228970 (View on PubMed)

Hayashi SY, Faintuch J, Yagi OK, Yamaguchi CM, Faintuch JJ, Cecconello I. Does Roux-en-Y gastrectomy for gastric cancer influence glucose homeostasis in lean patients? Surg Endosc. 2013 Aug;27(8):2829-35. doi: 10.1007/s00464-013-2829-3. Epub 2013 Feb 23.

Reference Type DERIVED
PMID: 23436087 (View on PubMed)

Other Identifiers

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Lessdiabetes

Identifier Type: -

Identifier Source: org_study_id

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