Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Colorectal Cancer Clinical Trial

Official title:

Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518023
• Other study ID #: Lessdiabetes
• Status: Completed
• Phase: N/A
• First received: January 20, 2012
• Last updated: January 24, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Diabetes Mellitus
• Gastric Cancer
• Glucose Intolerance
• Morbid Obesity
• Obesity, Morbid
• Prediabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose	Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association	3-12 years change	No
Secondary	HbA1c	Same as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.	3-12 years	No