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.

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Key information

Conditions

Diabetes Mellitus Body Weight Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Glucose Metabolism Disorders Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Morbid Obesity Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Rectal Diseases Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077

São Paulo, 05403-900, Brazil

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interview, questionnaire, updated biochemical tests

Other

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.

Primary outcomes

Fasting blood glucose

Time frame: 3-12 years change

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

Secondary outcomes

HbA1c

Time frame: 3-12 years

Same as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jan 25, 2012
Registry last updated: Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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