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Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy


N/A
18 Years
N/A
Not Enrolling
Both
Diabetes Mellitus, Prediabetes, Morbid Obesity, Gastric Cancer, Colorectal Cancer

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Trial Information

Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy


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;


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Fasting blood glucose

Outcome Description:

Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association

Outcome Time Frame:

3-12 years change

Safety Issue:

No

Principal Investigator

Joel Faintuch, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital das Clinicas, Sao Paulo, Brazil

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

Lessdiabetes

NCT ID:

NCT01518023

Start Date:

January 2011

Completion Date:

December 2011

Related Keywords:

  • Diabetes Mellitus
  • Prediabetes
  • Morbid Obesity
  • Gastric Cancer
  • Colorectal Cancer
  • diabetes mellitus
  • prediabetes
  • fasting blood glucose
  • HbA1c
  • Roux en Y gastric bypass
  • Cancer gastrectomy
  • Cancer colorectal surgery
  • Colorectal Neoplasms
  • Diabetes Mellitus
  • Stomach Neoplasms
  • Obesity
  • Obesity, Morbid
  • Glucose Intolerance
  • Prediabetic State

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