Clinical trial NCT01518023: Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
Official title: Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Prediabetes
Morbid Obesity
Gastric Cancer
Colorectal Cancer
Keywords: diabetes mellitus
prediabetes
fasting blood glucose
HbA1c
Roux en Y gastric bypass
Cancer gastrectomy
Cancer colorectal surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males and females submitted to elective curative operations will be enrolled

Brief 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.

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 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

Primary outcomes:
measure: Fasting blood glucose
timeFrame: 3-12 years change
Secondary outcomes:
measure: HbA1c
timeFrame: 3-12 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077
Study officials:
affiliation: Hospital das Clinicas, Sao Paulo, Brazil
name: Joel Faintuch, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
citation: 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.