Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association
研究概览
简要总结
Glucose homeostasis changes after distal pancreatectomy are not well understood. This study aim to identify the incidence of and risk factors for, a change in glucose homeostasis in patients who underwent distal pancreatic resection.
详细描述
The development of sophisticated surgical procedures, improved postoperative care, and the capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic resection. For these patients, the endocrine function of the pancreas is a critical factor that influences quality of life. In this study, the investigators recruit patients who underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10 years. Demographic characteristics, operative parameters and short-term postoperative outcomes were collected in a prospective database maintained by the Pancreatic Surgical Centre, Peking Union Medical College Hospital. These patients are followed up regularly by outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine the cumulative rates of endocrine insufficiency, and identify risk factors for DM development in a large cohort of patients undergoing distal pancreatectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing distal pancreatectomy
排除标准
- •Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation
- •Patients with preoperative DM
- •Patients with functioning insulinoma and multiple endocrine neoplasia type 1
结局指标
主要结局
Number of participants with new-onset diabetes mellitus as defined by American Diabetes Association
时间窗: Through study completion, an average of 3 year
The criteria for the diagnosis of diabetes developed by American Diabetes Association (1) FPG (fasting plasma glucose) ≥ 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.\* OR (2) 2-h PG (plasma glucose) ≥ 200 mg/dL (11.1mmol/L) during an OGTT (oral glucose tolerance test). The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.\* OR (3) A1C ≥ 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.\* (lower-upper limit: 4.5%-6.3% in PUMCH) OR (4) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L). \*In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing.
次要结局
- Number of participants with new-onset exocrine insufficiency(Through study completion, an average of 3 year)
- Number of participants with new-onset prediabetes as defined by American Diabetes Association(Through study completion, an average of 3 year)