Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
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
- 否
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
Joel Faintuch
Associate Professor, Department of Gastroenterology
University of Sao Paulo
