2 型糖尿病的胰腺形态特征 (PANDIAM)
2 型糖尿病患者胰腺的形态特征：与疾病临床特征的相关性。
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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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A Coruña
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Santiago de Compostela、A Coruña、西班牙、15706
- Hospital Clinico Universitario de Santiago
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult diabetic (patients) and nondiabetic (controls) undergoing endoscopic ultrasound for indications other than evaluation of the pancreas due to suspected or known pancreatic disease.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of pancreatic disease or surgery.
- History of upper gastrointestinal surgery.
- Diabetes type other than type-2.
- Severe cardiovascular or respiratory disease.
- Lack of informed consent.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Case
Cases are adult patients with type-2 diabetes, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
其他名称：
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Control
Controls are adult, non-diabetic patients, who undergo endoscopic ultrasound examination for any non-pancreatic indication. |
Evaluation of pancreatic fibrosis by endoscopic ultrasound and elastography. Evaluation of exocrine pancreatic function by fecal elastase-test and nutritional evaluation.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Degree of pancreatic fibrosis
大体时间：Day 1
|
Evaluation of the degree of pancreatic fibrosis by endoscopic ultrasound and elastography. |
Day 1
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|
Degree of impairment of exocrine pancreatic function
大体时间：Up to 7 days
|
Quantification of fecal elastase and evaluation of the nutritional status |
Up to 7 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of pancreatic atrophy
大体时间：Day 1
|
Size of the pancreas as evaluated by endoscopic ultrasound |
Day 1
|
|
Factors associated with pancreatic fibrosis
大体时间：Day 1
|
Demographics and clinical data significantly associated with pancreatic fibrosis |
Day 1
|
合作者和调查者
调查人员
- 首席研究员：J. Enrique Dominguez-Munoz, MD, PhD、University Hospital of Santiago de Compostela, Spain
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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