Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joel Faintuch, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01518023
First received: January 20, 2012
Last updated: January 24, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

Adult males and females submitted to elective curative operations will be enrolled

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518023

Locations
Brazil
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 10, 2014