Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 20, 2012
January 24, 2012
January 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01518023 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

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.

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;

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Diabetes Mellitus
  • Prediabetes
  • Morbid Obesity
  • Gastric Cancer
  • Colorectal 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.
  • Cancer gastrectomy
    Patients previously submitted to partial/total gastrectomy for gastric cancer
    Intervention: Other: Interview, questionnaire, updated biochemical tests
  • Colorectal cancer operation
    Patients previously submitted to right colectomy or rectosignoidectomy for cancer
    Intervention: Other: Interview, questionnaire, updated biochemical tests
  • Bariatric patients
    Morbidly obese participants who underwent antiobesity Roux-en-Y gastric bypass
    Intervention: Other: Interview, questionnaire, updated biochemical tests

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01518023
Lessdiabetes
No
Joel Faintuch, University of Sao Paulo
University of Sao Paulo
Not Provided
Study Chair: Joel Faintuch, MD, PhD Hospital das Clinicas, Sao Paulo, Brazil
University of Sao Paulo
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP