Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Degree of pancreatic fibrosis
研究概览
简要总结
Hypothesis: Type 2 diabetes mellitus is associated with pancreatic fibrosis that can be evaluated by minimally invasive imaging techniques. That fibrosis is associated with alteration of exocrine pancreatic function, defined as a reduced secretion of pancreatic enzymes and the development of nutritional deficiencies.
To test that hypothesis, a prospective, observational, cross-sectional, comparative, case-control study has been designed.
Pancreatic fibrosis will be evaluated by endoscopic ultrasound and quantitative elastography in cases (type-2 diabetes) and age-gender-matched controls without diabetes.
Pancreatic function will be explored by fecal elastase test and nutritional evaluation.
Calculated sample size is 94 patients (47 cases and 47 controls). Study period is 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients older than 18 years.
- •Undergoing an upper endoscopic ultrasound for any indication other than pancreatic disease.
- •Signed informed consent-
- •Patients: Previous diagnosis of type-2 diabetes mellitus.
- •Controls: Nondiabetic subjects, matched by age, gender, alcohol consumption, and smoking with patients.
排除标准
- •History of pancreatic disease or surgery.
- •History of upper gastrointestinal surgery.
- •Diabetes type other than type-
- •Severe cardiovascular or respiratory disease.
- •Lack of informed consent.
结局指标
主要结局
Degree of pancreatic fibrosis
时间窗: Day 1
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography.
Degree of impairment of exocrine pancreatic function
时间窗: Up to 7 days
Quantification of fecal elastase and evaluation of the nutritional status
次要结局
- Prevalence of pancreatic atrophy(Day 1)
- Factors associated with pancreatic fibrosis(Day 1)
研究者
J. Enrique Domínguez-Muñoz
Director of the Department of Gastroenterology
Hospital Clinico Universitario de Santiago