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临床试验/NCT01518023
NCT01518023已完成不适用

Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
Fasting blood glucose

研究概览

简要总结

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.

详细描述

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;

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Follow-up period > 3 years,
  • weight stable in the last year

排除标准

  • 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

结局指标

主要结局

Fasting blood glucose

时间窗: 3-12 years change

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

次要结局

  • HbA1c(3-12 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joel Faintuch

Associate Professor, Department of Gastroenterology

University of Sao Paulo

研究点 (1)

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